[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]
HEARING TO REVIEW THE ADVANCES OF
ANIMAL HEALTH WITHIN THE LIVESTOCK
INDUSTRY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON
LIVESTOCK, DAIRY, AND POULTRY
OF THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
THURSDAY, SEPTEMBER 25, 2008
__________
Serial No. 110-48
Printed for the use of the Committee on Agriculture
agriculture.house.gov
----------
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COMMITTEE ON AGRICULTURE
COLLIN C. PETERSON, Minnesota, Chairman
TIM HOLDEN, Pennsylvania, BOB GOODLATTE, Virginia, Ranking
Vice Chairman Minority Member
MIKE McINTYRE, North Carolina TERRY EVERETT, Alabama
BOB ETHERIDGE, North Carolina FRANK D. LUCAS, Oklahoma
LEONARD L. BOSWELL, Iowa JERRY MORAN, Kansas
JOE BACA, California ROBIN HAYES, North Carolina
DENNIS A. CARDOZA, California TIMOTHY V. JOHNSON, Illinois
DAVID SCOTT, Georgia SAM GRAVES, Missouri
JIM MARSHALL, Georgia MIKE ROGERS, Alabama
STEPHANIE HERSETH SANDLIN, South STEVE KING, Iowa
Dakota MARILYN N. MUSGRAVE, Colorado
HENRY CUELLAR, Texas RANDY NEUGEBAUER, Texas
JIM COSTA, California CHARLES W. BOUSTANY, Jr.,
JOHN T. SALAZAR, Colorado Louisiana
BRAD ELLSWORTH, Indiana JOHN R. ``RANDY'' KUHL, Jr., New
NANCY E. BOYDA, Kansas York
ZACHARY T. SPACE, Ohio VIRGINIA FOXX, North Carolina
TIMOTHY J. WALZ, Minnesota K. MICHAEL CONAWAY, Texas
KIRSTEN E. GILLIBRAND, New York JEFF FORTENBERRY, Nebraska
STEVE KAGEN, Wisconsin JEAN SCHMIDT, Ohio
EARL POMEROY, North Dakota ADRIAN SMITH, Nebraska
LINCOLN DAVIS, Tennessee TIM WALBERG, Michigan
JOHN BARROW, Georgia BOB LATTA, Ohio
NICK LAMPSON, Texas
JOE DONNELLY, Indiana
TIM MAHONEY, Florida
TRAVIS W. CHILDERS, Mississippi
______
Professional Staff
Robert L. Larew, Chief of Staff
Andrew W. Baker, Chief Counsel
April Slayton, Communications Director
William E. O'Conner, Jr., Minority Staff Director
______
Subcommittee on Livestock, Dairy, and Poultry
LEONARD L. BOSWELL, Iowa, Chairman
KIRSTEN E. GILLIBRAND, New York ROBIN HAYES, North Carolina,
STEVE KAGEN, Wisconsin Ranking Minority Member
TIM HOLDEN, Pennsylvania MIKE ROGERS, Alabama
JOE BACA, California STEVE KING, Iowa
DENNIS A. CARDOZA, California VIRGINIA FOXX, North Carolina
NICK LAMPSON, Texas K. MICHAEL CONAWAY, Texas
JOE DONNELLY, Indiana JEAN SCHMIDT, Ohio
JIM COSTA, California ADRIAN SMITH, Nebraska
TIM MAHONEY, Florida TIM WALBERG, Michigan
Chandler Goule, Subcommittee Staff Director
(ii)
C O N T E N T S
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Page
Boswell, Hon. Leonard L., a Representative in Congress from Iowa,
opening statement.............................................. 1
Prepared statement........................................... 2
Boyda, Hon. Nancy E., a Representative in Congress from Kansas,
prepared statement............................................. 6
Hayes, Hon. Robin, a Representative in Congress from North
Carolina, opening statement.................................... 3
Prepared statement........................................... 4
Peterson, Hon. Collin C., a Representative in Congress from
Minnesota, prepared statement.................................. 5
Witnesses
Clifford, D.V.M., John, Deputy Administrator for Veterinary
Services and Chief Veterinarian, Animal and Plant Health
Inspection Service, U.S. Department of Agriculture, Washington,
D.C.; accompanied by Rob Hedberg, Acting Director, Legislative
and Governmental Affairs, Cooperative State Research,
Education, and Extension Service, U.S. Department of
Agriculture.................................................... 6
Prepared statement........................................... 8
Dunham, D.V.M., Ph.D., Bernadette, Director, Center for
Veterinary Medicine, Food and Drug Administration, U.S.
Department of Health and Human Services, Rockville, MD......... 15
Prepared statement........................................... 17
Rowles, D.V.M., Craig, General Manager and Partner, Elite Pork
Partnership, Carroll, IA; on behalf of National Pork Producers
Council........................................................ 32
Prepared statement........................................... 34
Supplemental material........................................ 109
Rybolt, Ph.D., Michael L., Director, Scientific and Regulatory
Affairs, National Turkey Federation, Washington, D.C........... 37
Prepared statement........................................... 40
Byrne, Ph.D., Robert D., Senior Vice President, Scientific and
Regulatory Affairs, National Milk Producers Federation,
Arlington, VA.................................................. 41
Prepared statement........................................... 44
Klopp, D.V.M., D.A.C.P.V., Spangler, Corporate Veterinarian,
Townsends, Inc., Georgetown, DE; on behalf of National Chicken
Council........................................................ 47
Prepared statement........................................... 49
Van Zetten, Blair, President, Oskaloosa Food Products Corp.,
Oskaloosa, IA; on behalf of United Egg Producers............... 50
Prepared statement........................................... 52
Apley, D.V.M., Ph.D., D.A.C.V.P., Michael D., Associate Professor
of Beef Production Medicine, Clinical Pharmacologist, and
Director, PharmCATS Bioanalytical Laboratory, Kansas State
University; Member, Cattle Health and Well Being Committee,
National Cattlemen's Beef Association, Manhattan, KS........... 54
Prepared statement........................................... 55
Carnevale, V.M.D., Richard A., Vice President, Scientific,
Regulatory and International Affairs, Animal Health Institute,
Washington, D.C................................................ 64
Prepared statement........................................... 67
Supplemental material........................................ 110
Hoang, D.V.M., M.P.H., Christine N., Assistant Director,
Scientific Activities Division, American Veterinary Medical
Association, Schaumburg, IL.................................... 73
Prepared statement........................................... 75
Singer, D.V.M., M.P.V.M., Ph.D., Randall S., Associate Professor
of Epidemiology, Department of Veterinary and Biomedical
Sciences, College of Veterinary Medicine, and Division of
Environmental Health, School of Public Health, University of
Minnesota, St. Paul, MN........................................ 90
Prepared statement........................................... 117
Submitted Material
Keep Antibiotics Working, submitted statement.................... 102
Martin, Robert P., Executive Director, Pew Commission on
Industrial Farm Animal Production, submitted statement......... 108
Slaughter, Hon. Louise M., a Representative in Congress from New
York, submitted statement...................................... 99
Steuer, Karen, Director of Government Operations, Pew Campaign on
Human Health and Industrial Farming, submitted statement....... 105
Submitted questions.............................................. 117
HEARING TO REVIEW THE ADVANCES OF
ANIMAL HEALTH WITHIN THE LIVESTOCK
INDUSTRY
----------
THURSDAY, SEPTEMBER 25, 2008
House of Representatives,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.
The Subcommittee met, pursuant to call, at 10:04 a.m., in
Room 1300 of the Longworth House Office Building, Hon. Leonard
L. Boswell [Chairman of the Subcommittee] presiding.
Members present: Representatives Boswell, Kagen, Baca,
Peterson (ex officio), Hayes, Foxx, Smith, and Goodlatte (ex
officio).
Staff present: Adam Durand, Alejandra Gonzalez-Arias,
Chandler Goule, John Konya, John Riley, April Slayton, Rebekah
Solem, John Goldberg, Pam Miller, and Jamie Weyer.
OPENING STATEMENT OF HON. LEONARD L. BOSWELL, A REPRESENTATIVE
IN CONGRESS FROM IOWA
The Chairman. The hearing of the Subcommittee on Livestock,
Dairy, and Poultry to review the advances of animal health
within the livestock industry will come to order.
I appreciate you all being here and I first want to welcome
you and thank you for joining us today to discuss a very
important issue to rural America and food security across the
country. A special thanks to our witnesses for appearing before
the Subcommittee today, particularly from my territory, not
that everybody is not equally as important of course. But, I
want to call attention to Mr. Blair Van Zetten and Dr. Craig
Rowles, here not only to represent their respective industries
but my home state. Thank you very much for taking the time to
come.
Having spent most of my life involved in animal
agriculture, and knowing the responsibility of using
antibiotics, which I think all farmers do, I understand many of
the issues that affect the industry firsthand. I spent most of
my youth working in some aspect of livestock production, but
when I left the Army and moved back to Iowa to be in farming
again, I sat down with a local veterinarian that some of you
may know, Dr. McElroy. We discussed the use of antibiotics to
treat sick animals, prevent illness and to preserve the health
of those animals. As I discussed my experience with producers
and veterinarians, I learned this is not the exception but it
is the rule that I find that all producers live by. We
understand that it is something that is a very useful tool, but
we have to use it carefully, and we have to use it according to
the expectations of how to handle those antibiotics. For over
40 years, the U.S. animal agriculture industry has used FDA-
approved drugs to ensure we have healthy animals because
healthy animals produce healthy food.
Also, I would like to take a moment to highlight very
important programs for safe and efficient drug use, the Food
Animal Residue Avoidance Databank, known as FARAD, and the
Animal Drug User Fee Act, ADUFA. FARAD is a program that has a
computer-based decision-support system which provides producers
and veterinarians with practical information on how to avoid
antibiotic residues in food. FARAD helps protect our food
supply yet continually struggles for funding. In Fiscal Year
2008, FARAD received no funding, and this year is in danger of
shutting down completely. Ranking Member Hayes and I sent a
letter to both USDA and the FDA, in July, regarding this
critical issue, and I wanted to once again stress the
importance of getting this program funded.
I was pleased this year when Congress passed ADUFA, which
also plays a vital role in maintaining a healthy animal
agricultural industry. This critical program supports continued
improvements of FDA's review program and assists FDA in a
timely drug approval process.
I must be cautious when people outside the industry talk
about banning antibiotic use in livestock. I believe we must
follow a science-based process to ensure that unintended
consequences do not put human health at risk. I think a
compelling example of this is the Denmark case where the
removal of antibiotics for health maintenance or growth
purposes resulted not only in the use of more antibiotics to
treat animal disease, but also increased animal death and
disease. Antibiotic use in livestock has been a hot topic of
discussion for years, and this year is no exception.
In recent months, both sides of the Hill have held various
hearings over this subject. Today it is my hope that consumers
can put their faith in science-based evidence that the use of
antibiotics in animal agriculture not only gives us healthy
animals but also a safe food supply.
Once again, I would like to thank everyone for joining us
here today.
[The prepared statement of Mr. Boswell follows:]
Prepared Statement of Hon. Leonard L. Boswell, a Representative in
Congress from Iowa
Good morning, I would like to thank everyone for joining us today
to discuss a very important issue to rural America and food security
across the country. A special thanks to our witness for appearing
before the Subcommittee today, particularly Mr. Blair Van Zetten and
Dr. Craig Rowles who are here not only to represent their respective
industries but also the great State of Iowa.
Having spent most my life involved in animal agriculture and
responsibly using antibiotics, I understand many of the issues that
affect the industry first hand. I spent most of my youth working in
some aspect of livestock production but when I retired from the Army
and moved back to Iowa to begin farming I sat down with the local
veterinarian--Doc McElroy. We discussed the use of antibiotics to treat
sick animals, prevent illness, and to preserve the health of those
animals. As I have discussed my experience with producers and
veterinarians I learned this is not the exception but the rule.
For over 40 years the U.S. animal agriculture industry has used FDA
approved drugs to ensure we have healthy animals. Because healthy
animals produce healthy food.
I also would like to take a moment to highlight two very important
programs for safe and efficient drug use--the Food Animal Residue
Avoidance Databank (FARAD) and the Animal Drug User Fee Act (ADUFA).
FARAD is a program that has a computer-based decision-support
system which provides producers and veterinarians with practical
information on how to avoid antibiotic residues in food. FARAD helps
protect our food supply yet continually struggles for funding. In
Fiscal Year 2008, FARAD received no funding and this year is in danger
of shutting down completely. Ranking Member Hayes and I sent a letter
to both USDA and FDA, in July, regarding this critical issue and I
wanted to once again stress the importance of getting this program
funding. I was please this year when Congress passed ADUFA, which also
plays a vital role in maintaining a health animal agriculture industry.
This critical program supports continued improvements of FDA's review
program and assists FDA in a timely drug approval process.
I must be cautious when people outside the industry talk about
banning antibiotic use in livestock. I believe we must follow a
science-based process to ensure that unintended consequences do not put
human health at risk. I think a compelling example of this is the
Denmark case where the removal of antibiotics for health maintenance or
growth purposes resulted not only in the use of more antibiotics to
treat animal diseases but also increased animal death and disease.
Antibiotic use in livestock has been a hot topic of discussion for
years and this year is no exception. In recent months both sides of the
Hill have held various hearings over this subject. Today, it is my hope
that consumers can put their faith in science-backed evidence that the
use of antibiotics in animal agriculture not only gives us healthy
animals but also a safe food supply.
Once again, I would like to thank everyone for joining us here
today. At this time I would like to recognize my Ranking Member and
good friend Robin Hayes from North Carolina for any opening remarks he
would like to make.
The Chairman. At this time I would like to recognize my
Ranking Member and my good friend, Robin Hayes from North
Carolina, for any opening remarks that he would like to make.
Mr. Hayes.
OPENING STATEMENT OF HON. ROBIN HAYES, A REPRESENTATIVE IN
CONGRESS FROM NORTH CAROLINA
Mr. Hayes. Thank you, Mr. Chairman, and you are a good
friend and a trusted advisor. I had my sausage yesterday and
not today, so I may not be at my peak.
The Chairman. Oh, okay.
Mr. Hayes. Thank you, Mr. Chairman, for holding this
hearing relating to the use of antibiotics in animal
agriculture. Agricultural use of antibiotics has received quite
a bit of press lately. Unfortunately, the press coverage has
not provided the full picture on the issue. It has not given
adequate attention to the factual information surrounding the
use of antibiotics for animal agriculture, and why it is so
important that farmers have the ability to administer
antibiotics to their livestock. The veterinary community, as
well as farmers and ranchers, can attest to the fact that
banning antibiotics will impose substantial cost on producers
and provide no quantifiable public health benefit. Farmers have
an economic incentive to keep their herd healthy. Obviously,
livestock farmers would be discriminating in the frequency and
quantity of the antibiotics they administer to prevent the
adulteration of their product. At the same time, judicious use
of antibiotics is necessary for both prevention and treatment
of disease.
One example of how a ban on antibiotics in animal
agriculture can negatively impact the health of livestock is
the instance that you referred to in Denmark. I won't go into
detail. I will insert that in the record. You are looking at
increased death and disease in herds, a 135 percent increase in
the amount of antibiotics used to treat animal disease between
1996 and 2005. Denmark is now using more antibiotics for
treatment as a result of banning its use for prevention. There
is no evidence that we are aware of to demonstrate that the
decline in antibiotic resistance in humans is a result of the
ban. The net result of the ban is an increase in disease and
death in swine herds that discontinued use. Yet there is no
evidence to suggest this ban resulted in a reduction of
resistance.
Mr. Chairman, many of our colleagues simply have no
understanding of the challenges confronting animal agriculture.
For them it would seem to be an easy decision to vote for
legislation that imposes arbitrary restrictions on food
producers under the mistaken assumption that they are helping
address concerns in human medicine. Based on the Danish
experiments and the balance of today's testimony, I think we
can fairly conclude they would be mistaken.
I appreciate you holding the hearing, and I might also add
that our purpose is to confirm and reaffirm the quality and
safety of the American livestock industry's product. This
hearing will create additional oversight but also insight by
exchanging ideas, experiences and results of stringent testing
and evaluation. So I thank our witnesses and I thank our
Chairman. Let us proceed.
[The prepared statement of Mr. Hayes follows:]
Prepared Statement of Hon. Robin Hayes, a Representative in Congress
from North Carolina
Thank you, Mr. Chairman, for holding this hearing relating to the
use of antibiotics in animal agriculture. Agricultural usage of
antibiotics has received quite a bit of press lately. Unfortunately,
the press coverage has not provided the full picture on this issue. It
has not given adequate attention to the factual information surrounding
the use of antibiotics for animal agriculture, and why it is so
important that farmers have the ability to administer antibiotics to
their livestock.
The veterinary community, as well as farmers and ranchers, can
attest to the fact that banning antibiotics will impose substantial
costs on producers and provide no quantifiable public health benefit.
Farmers have an economic incentive to keep their herd healthy.
Obviously, livestock farmers would be discriminating in the frequency
and quantity of the antibiotics they administer to prevent the
adulteration of their product. At the same time, the judicious use of
antibiotics is necessary for both the prevention and treatment of
disease.
One example of how a ban on antibiotics in animal agriculture can
negatively impact the health of livestock happened in Denmark.
* * * * *
In the late 1990s, Denmark instituted a voluntary ban on the use of
antibiotics for growth promotion in feed; a compulsory ban was
initiated in 2000. Since then the pork industry in Denmark, which has
about the same number of swine as the State of Iowa, bas experienced
the following as a result of this ban:
Increased death and disease in the swine herds.
135% increase in the amount of antibiotics used to treat
animal disease between 1996 and 2005. So, Denmark is now using
more antibiotics for treatment as result of banning its use for
prevention.
Overall mixed results. Resistance to some antibiotics has
decreased, while resistance to others has increased.
And, there is no evidence that we're aware of to demonstrate
a decline in antibiotic resistance in humans as a result of
this ban.
The net result of the ban is an increase in disease and death in
the swine herds that discontinued use. Yet, there is no evidence to
suggest that this ban resulted in a reduction of antibiotic resistance
patterns in humans.
* * * * *
Mr. Chairman, many of our colleagues simply have no understanding
of the challenges confronting animal agriculture. For them, it would
seem to be an easy decision to vote for legislation that imposes
arbitrary restrictions on food producers under the mistaken assumption
that they are helping address concerns in human medicine.
Based on the Danish experiment and the balance of today's testimony
I think we can fairly conclude that they would be mistaken. I
appreciate your holding this hearing so that we can all make this point
on the record. I yield back.
The Chairman. Thank you, Mr. Hayes, and thank you for being
here. We are going to follow the normal routine, move on to
witnesses and welcome any statements that Members want to put
into the record. Also, you will be recognized when we get to
question time.
[The prepared statements of Mr. Peterson and Mrs. Boyda
follow:]
Prepared Statement of Hon. Collin C. Peterson, a Representative in
Congress from Minnesota
First, I want to thank Chairman Boswell for holding this hearing. I
also want to recognize two of the witnesses who have Minnesota ties.
Dr. Randall Singer is a Professor of Epidemiology at the University of
Minnesota's College of Veterinary Medicine and Dr. Christine Hoang, who
is here on behalf of the American Veterinary Medical Association,
graduated from the University. Thanks to both of you and to all of our
witnesses here today.
The livestock industry faces numerous challenges in today's market.
Energy and other input prices are squeezing producers. Local, state and
Federal regulations and requirements impose all kind of restrictions on
their operations. Producers are being blamed by some for increasing
antibiotic resistance in humans because they treat their animals with
antibiotics.
Like so many issues, the problem of antibiotic resistance is
complicated, and there is not a single cause or simple solution.
Without a doubt, antibiotic resistance is a serious public health
problem, and we need to be sure that we take responsible steps to
address it.
The responsible use of antibiotics in animal agriculture decreases
mortality rates and disease and increases food safety. The overuse of
antibiotics, on the other hand, is clearly not acceptable. Professional
associations and industry leaders in animal agriculture must lead in
the development of best management practices and guidelines for
responsible antibiotic use in livestock, and in educating producers
about those practices. I am looking forward to hearing from those
groups testifying here today about their education and outreach efforts
on this issue and the results they are seeing among producers.
There are some who would like to blame antibiotic resistance in
humans on animal agriculture. I want to be clear that banning
antibiotics from animal agriculture will have serious consequences and
will not solve the problems we are seeing with antibiotic resistance.
Without antibiotics, the supply of meat, poultry, dairy and eggs would
decline at a time when demand for these products around the world is on
the rise. In addition, banning antibiotics in animal agriculture will
increase consumers' exposure to pathogens that cause foodborne
illnesses and at the same time will increase food costs.
I hope that in the testimony presented here today, we can get a
better understanding of where we are in terms of antibiotic resistance
in human as well as animal health. I appreciate Dr. Clifford from USDA
and Dr. Dunham from FDA for joining us. This is an important issue, and
we need to know what the facts are and what the implications would be
if we severely restricted or banned the use of antibiotics in animal
agriculture.
Chairman Boswell, thank you again for holding this hearing, and I
look forward to the testimony from our witnesses.
______
Prepared Statement of Hon. Nancy E. Boyda, a Representative in Congress
from Kansas
Chairman Boswell and Ranking Member Hayes, thank you for holding
this hearing to review animal health. I appreciate the Committee
addressing a subject so important to the Second District of Kansas.
Although I am not a Member of the Subcommittee, I wanted to share
my support for continued oversight and research into animal research.
In particular, more research is needed into the link or lack thereof
between antibiotics in animal feed and resistance to antibiotics in
humans.
I'd also like to take this opportunity to highlight the important
research occurring in Kansas and Missouri and encourage support for H.
Res. 829, which recognizes the region from Manhattan, Kansas, to
Columbia, Missouri, as the Kansas City Animal Health Corridor. The
Animal Health Corridor is home to 45 companies involved in the animal
health industry; more than 120 companies involved in the animal health
industry are located in Kansas and Missouri, including four of the ten
largest global animal health companies and one of the five largest
animal nutrition companies.
Several leading veterinary colleges and animal research centers are
located in Kansas and Missouri, including the College of Veterinary
Medicine and the $54,000,000 Biosecurity Research Institute of Kansas
State University and the College of Veterinary Medicine, the College of
Agriculture, Food and Natural Resources' Division of Animal Sciences,
the $60,000,000 Life Sciences Center, the National Swine Resource and
Research Center, and the Research Animal Diagnostic Laboratory of the
University of Missouri. Additionally, more than 45 percent of the fed
cattle in the United States, 40 percent of the hogs produced, and 20
percent of the beef cows and calves are located within 350 miles of
Kansas City. H. Res. 829 would highlight the research taking place in
Kansas and Missouri, and encourage more companies to relocate to the
area.
Thank you again for allowing me the opportunity to address the
Subcommittee.
The Chairman. We will start with our first panel, and I
think we will recognize Dr. Clifford first and then Dr. Dunham.
Dr. John Clifford, Doctor of Veterinary Medicine, is the Deputy
Administrator, Animal and Plant Health Inspection, U.S.
Department of Agriculture, Washington, D.C. So Dr. Clifford,
please begin when you are ready, and thank you for your
presence.
STATEMENT OF JOHN CLIFFORD, D.V.M., DEPUTY
ADMINISTRATOR FOR VETERINARY SERVICES AND CHIEF VETERINARIAN,
ANIMAL AND PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT OF
AGRICULTURE,
WASHINGTON, D.C.; ACCOMPANIED BY ROB HEDBERG,
ACTING DIRECTOR, LEGISLATIVE AND GOVERNMENTAL
AFFAIRS, COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION
SERVICE, U.S. DEPARTMENT OF
AGRICULTURE
Dr. Clifford. Thank you, Mr. Chairman. My name is John
Clifford. I am the Deputy Administrator for Veterinary Services
with the Department of Agriculture's Animal and Plant Health
Inspection Service, or APHIS. Thank you for this opportunity to
testify before you.
My agency's role in advancing livestock health is
multifaceted. At any given time, APHIS is working to safeguard
the health of U.S. livestock against foreign animal diseases,
eradicate and control diseases that exist in the United States,
and conduct surveillance related to issues affecting animal
health. Important advances have been realized in all of these
areas in recent years to the benefit of the U.S. livestock
industry. This morning I would like to highlight for you
APHIS's emergency planning and response efforts, the
brucellosis program and our efforts related to the use of
antibiotics in livestock.
As USDA's Chief Veterinary Officer, I believe one of the
most important ways of protecting and advancing livestock
health is to ensure that we have a strong system in place to
safeguard against animal diseases. Foreign animal disease
incursions and other animal health emergencies can have a major
impact on America. For example, studies have projected that an
outbreak of foot-and-mouth disease contained in California
could cost between $6 billion and $14 billion.
The U.S. response to animal health emergencies involves a
partnership between Federal, state and industry cooperators. In
support of this effort, APHIS develops emergency response
plans, operates the nation's repository of vaccines, personal
protective equipment and other critical supplies and equipment,
and provides laboratory and diagnostic services. Written
response plans have been developed and tested for the most
dangerous animal diseases that pose a risk to U.S. agriculture
including highly pathogenic avian influenza and foot-and-mouth
disease. Since its establishment in 2000, the National Animal
Health Emergency Response Corps has deployed over 500
volunteers to assist Federal and state responders during animal
health emergencies and our National Animal Health Laboratory
Network continues to grow with a current total of 58
laboratories in 45 states. All the above preparations have us
well positioned to safeguard livestock in the United States.
In the event that a disease of concern is introduced or has
existed in the United States, APHIS works with the livestock
industry and states to eradicate and control the disease. One
of APHIS's longstanding programs is our brucellosis program.
This program has been highly effective, and in 1956 we had
124,000 affected herds in the United States as a result of
testing. By 1992, that number had dropped to 700. As of today,
there are only two known affected domestic cattle herds
remaining in the entire United States. Also, annual
brucellosis-related losses due to aborted fetuses, reduced
breeding efficiency and lowered milk production had decreased
from more than $400 million in 1952 to almost zero today.
In addition to safeguarding against diseases that affect
livestock health, APHIS also collaborates with other Federal
agencies and the livestock industry to conduct surveillance and
collect data related to animal health issues such as the use of
antibiotics in livestock. One of these cooperative efforts is
the National Antimicrobial Resistance Monitoring System, or
NARMS. The NARMS was established in 1996 by USDA, the
Department of Health and Human Services, as well as other
cooperators. That system provides data on the prevalence of
antibiotic resistance in animals, humans and retail foods.
APHIS contributes by providing isolates from clinically ill
animals and isolates from healthy animals on farms. For
example, APHIS in collaboration with the U.S. Department of
Agriculture's Agricultural Research Service collects samples to
be cultured for bacteria, which are subsequently evaluated for
antimicrobial drug resistance as part of the NARMS.
In 2003, APHIS, ARS and USDA's Food Safety Inspection
Service undertook a pilot project that was designed to
complement NARMS. This pilot project was the Collaboration in
Animal Health and Food Safety Epidemiology and it was
established to examine bacterial resistance to antimicrobial
drugs on farms and to evaluate the potential for resistant
organisms to persist in food products from the animals under
study. The project was concluded in 2005.
In closing, I believe we will continue to see advances
within animal health and the livestock industry. Partnerships
with the livestock industry, states and other stakeholders will
continue to be critical in realizing advances in our livestock
industry.
Thank you for the opportunity to testify this morning, and
I will be pleased to answer any of your questions.
[The prepared statement of Dr. Clifford follows:]
Prepared Statement of John Clifford, D.V.M., Deputy Administrator for
Veterinary Services and Chief Veterinarian, Animal and Plant Health
Inspection Service, U.S. Department of Agriculture, Washington, D.C.
Chairman Boswell, Ranking Member Hayes, thank you for the
opportunity to testify before the Committee this morning. My name is
Dr. John Clifford and I am the Deputy Administrator for Veterinary
Services with the Department of Agriculture's (USDA) Animal and Plant
Health Inspection Service (APHIS). In this position, I also serve as
USDA's Chief Veterinary Officer.
Today, the Committee is looking at an important issue--advances of
animal health within the livestock industry. We at USDA are actively
engaged in developing and utilizing innovative methods to provide
leadership on food, agriculture, natural resources, and related issues
based on sound public policy, the best available science, and efficient
management.
In furtherance of this mission, APHIS is the agency within USDA
responsible for protecting and promoting U.S. agricultural health,
administering the Animal Welfare Act, and carrying out wildlife damage
management activities. Within APHIS, Veterinary Services protects and
improves the health, productivity, quality, and marketability of
animals, animal products, and veterinary biologics in the United
States. Partnerships with the livestock industry, as well as other
global and domestic stakeholders, are critical in accomplishing this
mission.
At any given time, my agency is working on multiple priorities in
order to ensure the health of our nation's domestic animal resources.
These priorities include safeguarding against foreign animal diseases,
emergency planning and preparedness, animal disease eradication and
control, and monitoring and surveillance for animal diseases. I am very
pleased to provide the following outline of some of the advances that
have been realized in these important areas.
Foreign Animal Diseases
While I am going to look broadly at several components of USDA's
programs that assist in advancing livestock health, including several
of those that look at the use of antibiotics in production practices, I
want to start with an area that is critical to me as the Chief
Veterinary Officer. In my mind, one of the most important ways of
protecting and advancing livestock health is to ensure we have a strong
system for preventing and responding to animal diseases.
Foreign animal diseases (FAD) represent an ongoing threat to human
health and to the health of the U.S. agricultural industry. We expect
that these diseases will continue to be of major concern because of
increased trade and increased movement of people, animals, and
pathogens. This fiscal year, we expect U.S. agriculture exports to
reach approximately $114 billion, making it the highest export sales in
a 12 month period ever in our history. U.S. agriculture imports are
rising as well--increasing from nearly $58 billion in 2005 to an
estimated $79 billion this fiscal year. APHIS works diligently with
state animal health officials and veterinary professionals to protect
U.S. agriculture from the introduction of animal diseases and to
identify, control, and eradicate animal diseases and diminish their
impact.
Efforts to detect FAD events in the United States include
surveillance in disease-specific programs, reporting by producers and
private veterinarians, and field investigations conducted by specially
trained Federal, state, and private accredited veterinarians.
Additional detection efforts include state diagnostic laboratory
surveillance, in which routine cases that are subsequently considered
``suspicious'' for FADs are reported to Federal and state animal health
authorities for further investigation. Early identification and quick
response in the FAD investigations are critical steps to ensuring that
any further spread is minimized.
Several important events have occurred globally over the last few
years involving foreign animal diseases, including foot-and-mouth
disease (FMD) and exotic Newcastle disease. A few of these events have
highlighted the importance of our emergency preparedness and response
capabilities. Most recently, highly pathogenic avian influenza (HPAI)
subtype H5N1 virus has captured global attention as a potential human
and animal health threat.
Preventing, preparing for, and responding to potential outbreaks of
avian influenza (AI) require collaboration on the broadest scale.
Successfully protecting avian health depends on our ability to work
together effectively--across all levels of government, with private
industry and the public, and around the world. This includes working
with the World Organization for Animal Health (OIE), which sets
international standards concerning diseases that affect human and
animal health, the United Nations' Food and Agriculture Organization
(FAO) and World Health Organization (WHO).
Internationally, we are collaborating with a variety of partners to
control, and eradicate HPAI in those countries where it currently
exists, and to prevent its introduction into the United States and
other areas. For example, APHIS works with its partners to identify
reservoirs of the disease and develop biosecurity recommendations for
farmers; conduct intensive diagnostic training sessions to expand
international diagnostic resources; and offer funding, technical
expertise, and equipment to countries affected by or at risk for HPAI.
On the domestic front, APHIS has partnered with other Federal and
state agencies and the commercial poultry industry in conducting
surveillance efforts for AI for many years. APHIS implemented
strategies to strengthen existing AI surveillance where necessary in
2006, and continued the enhanced surveillance efforts in 2007. We also
increased our AI preparedness by refining our response plans and
strengthening existing core programs in 2007.
Because of heightened animal- and public-health concerns, the
poultry industry and state and Federal animal-health regulatory
agencies are continuing efforts to increase biosecurity measures and
conduct extensive surveillance for HPAI, as well as certain subtypes of
low pathogenic avian influenza (LPAI), in commercial poultry, live-bird
markets, and poultry raised in non-confinement operations. The H5 and
H7 subtypes of LPAI are of concern because they have the potential to
mutate into highly pathogenic forms. This is why we established
regulations for a new monitoring and control program for the H5 and H7
subtypes for LPAI in 2006.
In addition, in partnership with the U.S. Department of the
Interior's U.S. Geological Survey and U.S. Fish and Wildlife Service,
APHIS' Wildlife Services program monitors wild birds for AI. Bird
banding data are used in conjunction with U.S. Census of Agriculture
data to rank counties with a high prevalence of domestic poultry
production and relatively high numbers of migrant waterfowl to identify
areas of critical concern and overlap between commercial poultry
production and concentrations of migratory waterfowl.
We at APHIS are proud of the success of our AI prevention efforts
to date. And it is worth reminding ourselves that, in addition to
routinely addressing outbreaks of LPAI, the United States has
effectively eradicated outbreaks of HPAI in three past instances, in
1924, 1983, and 2004.
Emergency Planning and Preparedness
Foreign animal disease incursions, as well as other animal health
emergencies, can have a major impact on America's infrastructure,
animal and public health, food safety, economy, and export markets. For
example, an outbreak of FMD in the United States could have significant
economic impacts. There are many susceptible animals in the United
States, including 96 million cattle, 61 million swine, and almost nine
million sheep and goats. The 2001 outbreak in the United Kingdom cost
an estimated 8 billion ($13 billion) and reduced the
British gross domestic product by 0.2 percent. Studies have projected a
cost of between $6 and $14 billion for a U.S. outbreak contained to
California. The impact comes primarily from lost international trade,
followed by costs directly associated with the eradication effort
including the expenses of depopulation, indemnity, carcass disposal,
and cleaning and disinfecting. In addition there are direct and
indirect costs related to lost production, unemployment, and losses in
related businesses.
APHIS' Veterinary Services (VS) program is charged with preventing
animal health emergencies in the United States, rapidly detecting such
emergencies should they occur, and responding effectively to control or
eradicate them.
The U.S. emergency response to animal health emergencies involves a
partnership between various Federal, state, tribal, local, industry,
and other private-sector cooperators. Written response plans and
guidelines address all areas of an emergency response, such as the
initial field investigation; local disease control and eradication
activities; emergency management, including line of command, planning,
logistics, and resources; and interagency coordination. Written
response plans have been developed for the most dangerous animal
diseases that pose a risk to U.S. agriculture, including HPAI and foot-
and-mouth disease.
Disease outbreaks throughout the past several years have
demonstrated the critical need for surge capacity personnel during an
animal health emergency. In 2000, APHIS created the National Animal
Health Emergency Response Corps (NAHERC) to provide a volunteer reserve
of veterinary professionals to assist Federal and state responders
during an animal health emergency. In 2001, 145 NAHERC members deployed
to the FMD outbreak in the United Kingdom. In 2003, 340 NAHERC
personnel assisted in the exotic Newcastle disease outbreak in
California and 71 NAHERC personnel responded to a LPAI outbreak in
Virginia. Their efforts were critical in protecting the nation's
livestock from these diseases.
During an emergency, APHIS is responsible for rapidly deploying
critical veterinary supplies and personal protective equipment for
workers from the National Veterinary Stockpile (NVS). The NVS was
established in February 2004 through Homeland Security Presidential
Directive--9 (HSPD-9). HSPD-9 reflects concerns that terrorists could
simultaneously, and in multiple locations, release catastrophic animal
diseases. The mission of the NVS is to deliver critical veterinary
supplies nationwide within 24 hours.
In 2007, the NVS continued expanding its capabilities. It acquired
personal protective equipment and antiviral medications against AI to
protect 3,000 responders, portable vaccine storage containers for field
use, emergency air and ground transportation contracts to ensure
deployment within 24 hours, and satellite phones to provide reliable
emergency voice and data communications, anywhere, anytime. It also
established commercial partnerships with all-hazard response companies
to provide large numbers of trained, experienced personnel with
equipment to help states depopulate, dispose, and decontaminate if they
do not have enough of their own personnel. Looking forward, the NVS is
working with the Department of Homeland Security to acquire next-
generation FMD vaccines and to quickly deliver current vaccines should
an FMD emergency occur.
Laboratory and diagnostic services are an essential component of
the U.S. emergency response to animal health emergencies. The National
Animal Health Laboratory Network (NAHLN) is part of a national strategy
to coordinate the activities of Federal, state, and university
laboratories providing critical animal disease surveillance and
testing. The NAHLN is a cooperative effort between two U.S. Department
of Agriculture (USDA) agencies--APHIS and a portion of the Cooperative
State Research, Education, and Extension Service's (CSREES) Integrated
Activities program--and the American Association of Veterinary
Laboratory Diagnosticians.
The USDA Homeland Security Office established the NAHLN as part of
a national strategy to coordinate and link the testing capacities of
the Federal veterinary diagnostic laboratories with the extensive
infrastructure (facilities, professional expertise, testing capacity,
and support) of state and university veterinary diagnostic
laboratories. This network enhances the nation's early detection of,
response to, and recovery from animal health emergencies, including
emerging diseases and FADs that threaten the nation's food supply and
public health.
In 2002, APHIS and CSREES initiated the network by entering into
cooperative agreements with 12 state and university veterinary
diagnostic laboratories. These were funded by the Department of
Homeland Security. APHIS now contracts with 54 state and university
diagnostic laboratories to assist with testing and surveillance; the
number of NAHLN facilities totals 58 laboratories in 45 states, which
includes those 54 laboratories plus the National Veterinary Services
Laboratories (NVSL), the Department of the Interior (DOI) laboratory in
Madison, WI; and the Food Safety and Inspection Service (FSIS)
laboratory in Athens, GA. All of the above preparations have us well
positioned to respond to animal health emergencies and to safeguard the
animal health in the United States.
Animal Disease Eradication and Control Programs
In the event diseases are introduced or have existed in the United
States, a key component of APHIS' VS program is its role in
eradicating, controlling, or preventing diseases that threaten the
biological and commercial health of U.S. livestock and poultry
industries. Diseases targeted in VS eradication programs include
scrapie in sheep and goats, tuberculosis in cattle and cervids,
pseudorabies and brucellosis in swine, and brucellosis in cattle and
bison.
APHIS' animal disease control and eradication programs generally
include many of the same features. The programs center on regulatory
measures that include, for example, quarantines to stop the movement of
possibly infected or exposed animals; the establishment of state
statuses, including regions or zones located therein that allow us to
fight infection while enabling commerce to continue; testing and
examination to detect infection; destruction of infected (sometimes
exposed) animals to prevent further disease spread; treatment to
eliminate parasites; vaccination in some cases; and cleaning and
disinfection of contaminated premises. Advancements in these program
areas have come through exhaustive work with states and industry over
the years. There have been successes in several key eradication
programs.
Pseudorabies
One eradication program that has seen significant advances over the
years is the pseudorabies program. Pseudorabies emerged as an
economically important disease of swine in the late 1960s. After a
virulent strain of pseudorabies virus (PRV) caused concentrated
outbreaks in the Midwest in the 1970s, the Livestock Conservation
Institute (now the National Institute for Animal Agriculture) set up a
task force in the 1980s that defined two state stages and established
the National Pseudorabies Control Board to oversee and determine the
status of each state. In 1989, APHIS published the program standards
for a plan to eradicate pseudorabies from commercial swine production
by 2000. By 1999, the U.S. infection rate was down to less than one
percent of all swine herds (about 1,000 herds), and the Accelerated
Pseudorabies Eradication Program was established to remove the last
infected domestic commercial herds through depopulation by the end of
2004, but accomplished this by early 2003.
Conducted in cooperation with state governments and swine
producers, the National Pseudorabies Eradication Program eliminated
pseudorabies from domestic commercial herds in all states, Puerto Rico,
and the U.S. Virgin Islands by the end of 2004. As documented in the
Pseudorabies Program Standards, program measures are based on
prevention, vaccination (now largely discontinued), disease
surveillance, and eradication. Primary program activities include
surveillance, herd certification, and herd cleanup.
Currently, there are no known domestic production swine herds
infected with PRV in the United States. Nationally, 18 transitional
herds, which are any herds with pigs that were exposed to feral or wild
pigs, were disclosed through surveillance as infected with PRV during
FY 2007. All herds were depopulated promptly. Complete epidemiologic
investigations of all cases disclosed no evidence that infection had
spread from the infected transitional herds to any contact herds.
Extensive surveillance activities over the past 3 years also suggest
that no commercial production farms have been infected.
A comprehensive surveillance plan for PRV, specifically for rapidly
detecting PRV introduction into commercial swine, was completed in
2007. Although pseudorabies has been eradicated from commercial
production swine, it is still endemic in feral swine and can be found
occasionally in transitional swine herds. The distribution of feral
swine continues to expand, with an estimated three million to four
million feral swine now located in at least 35 states. Therefore,
surveillance for PRV continues to be a priority for APHIS, particularly
with respect to addressing the new challenge of wildlife disease
reservoirs in feral swine populations. This prioritization of
pseudorabies is consistent with the sense of Congress in the Food,
Conservation, and Energy Act of 2008 (P.L. 110-246, 122 Stat. 1651)
that pseudorabies eradication is a high priority the Secretary of
Agriculture should carry out under the Animal Health Protection Act (7
U.S.C. 8301 et seq.).
Brucellosis
Another animal disease eradication program that I would like to
highlight for you is the brucellosis program. USDA has been working
with state and industry cooperators to eradicate brucellosis for many
years. The disease affects numerous species of animals, including
humans, and is caused by the bacteria Brucella abortus. Cattle, bison,
and elk are especially susceptible to the disease.
The Brucellosis Eradication Program was launched on a national
scale in 1934, and a cooperative effort among the Federal Government,
states, and livestock producers began in 1954. All states participate
in APHIS' Cooperative State-Federal Brucellosis Eradication Program and
are assigned a brucellosis classification by APHIS. These
classifications--Class Free, Class A, Class B, and Class C--are based
on herd prevalence rates for the disease and require various levels of
movement restrictions and surveillance activities. Most importantly to
cattle producers, restrictions on moving cattle interstate become less
stringent as a state approaches or achieves Class Free classification.
The program has been highly effective. In 1956, 124,000 affected
herds were found in the United States as a result of testing. By 1992,
this number had dropped to 700, and as of today, there are only four
known affected domestic cattle or bison herds remaining in the entire
United States. Currently, 49 states, Puerto Rico, and the U.S. Virgin
Islands are considered free of brucellosis. Montana is the last
remaining Class A status state. I am also pleased to report that annual
brucellosis-related losses due to aborted fetuses, reduced breeding
efficiency, and lowered milk production have decreased from more than
$400 million in 1952 to almost zero today.
The Greater Yellowstone Area (GYA), which encompasses approximately
20 million acres in three states, is the last known reservoir of
brucellosis in wild elk and bison in the United States. While
management of the disease is our approach for the near term, our long
term goal is to eliminate brucellosis from GYA wildlife, along with
protecting the elk and bison populations from the disease. I should
note that brucellosis in elk is widespread across the entire GYA, and
indications are that all disease transmissions from wildlife to cattle
in the GYA have come from elk. Transmission can occur through direct
contact between infected elk or bison and non-infected cattle if they
are allowed to co-mingle. Approximately 90 percent of GYA elk fall
under state jurisdiction during the summer season.
Surveillance testing of wild bison from the Yellowstone herd
indicates that approximately 50 percent of the bison in the 2 million
acre Park have been exposed to and are potentially infected with the
disease. This disease reservoir poses a risk to cattle that graze on
lands adjacent to the Park.
APHIS works with the GYA States, the cattle industry, and the
National Park Service to address the risk of brucellosis transmission
from wildlife leaving the Park to cattle that graze in surrounding
areas. Our sister agency within USDA, the U.S. Forest Service, also
plays a key role in managing the public lands on the Gallatin National
Forest, adjacent to Yellowstone National Park in Montana. The current
Interagency Bison Management Plan carefully balances the need to
preserve the Yellowstone bison herd with the need to prevent the spread
of brucellosis from bison to cattle.
USDA and the Department of the Interior (DOI) believe the next step
is to develop a long-term plan for the elimination of brucellosis from
the GYA. USDA and DOI have agreed to a draft a Greater Yellowstone
Interagency Brucellosis Committee (GYIBC) Memorandum of Understanding
and have forwarded it to the Governors of Idaho, Montana, and Idaho for
their review and signature.
Monitoring and Surveillance for Diseases That Affect Production and
Marketing
A key role of APHIS is the monitoring and surveillance for diseases
of major impact on animal production and marketing. This includes
monitoring animal health and production trends; facilitating the use of
new technologies for early and rapid disease detection, response, and
data analysis; and capturing, analyzing, interpreting, and
disseminating data using standardized methods.
National Animal Identification System (NAIS)
One of our more recently developed technologies for swift and
effective disease response is the National Animal Identification
System, or NAIS. NAIS is a modern, streamlined information system that
helps producers and animal health officials respond quickly and
effectively to animal disease events in the United States. from the
beginning, NAIS has been a cooperative effort among states, APHIS, and
industry.
There are three components of NAIS--premises registration, animal
identification, and animal tracing. Through NAIS, APHIS' ultimate,
long-term goal is to have the capacity to identify all premises and
animals that have had contact with a FAD or domestic animal disease of
concern within 48 hours after its discovery.
Our initial focus in developing NAIS has been to encourage farmers
and ranchers to register their premises. Registering premises provides
animal health officials with the key information needed to conduct
disease investigations quickly and efficiently. To date, more than
482,000 premises had been registered within the states, tribes and
territories. This total represents more than 34 percent of the
estimated number of premises nationwide. Thanks to the support and
outreach efforts of our state and industry partners, NAIS continues to
build momentum.
APHIS is also working to accelerate participation in the animal-
identification component of the system. In terms of animal tracing,
we've established 14 state and private databases to keep track of
animal movements. We've also developed a system that will allow
authorized state and Federal animal health officials to request
information from these databases during an animal disease event.
By working together with the public and with our partners, we will
continue to increase our ability to respond to animal diseases and
guarantee that we are successful in protecting the health and
marketability of American agriculture.
Data Collection and Other Activities Related to the Use of Antibiotics
in Livestock
Another area where APHIS, along with other agencies with the USDA,
has contributed to advances in the livestock industry is in the
collection of data related to animal health issues using standardized
methods. Over the past several years, one such issue that has captured
national attention is the use of antibiotics in livestock.
As you may know, several Federal agencies have in place programs to
learn more about, track, and reduce antimicrobial resistance in
animals. Many of these activities are joint activities among several
Federal agencies and are supported by the agricultural industries. In
fact, in 1999, the U.S. Interagency Task Force on Antimicrobial
Resistance was created to develop a national plan to combat
antimicrobial resistance. The Task Force is co-chaired by the Centers
for Disease Control and Prevention, the Food and Drug Administration
(FDA), and the National Institutes of Health and also includes USDA,
the Agency for Healthcare Research and Quality, the Health Care
Financing Administration, the Health Resources and Services
Administration, the Department of Defense, the Department of Veterans
Affairs, and the Environmental Protection Agency. Within USDA, agencies
that have contributed to the Task Force activities include APHIS, the
Agricultural Research Service (ARS), the Food Safety and Inspection
Service (FSIS), and CSREES.
The first is surveillance. In 1996, HHS and USDA, in cooperation
with several state and local health departments, established the
National Antimicrobial Resistance Monitoring System--NARMS. The goal of
the system is to provide data on the prevalence of antibiotic
resistance in animals, humans, and retail foods. This monitoring system
has been operating for about 10 years and has provided critical
information on emerging resistance trends. USDA supports NARMS through
three of its agencies. FSIS contributes isolates from its regulatory
program for Salmonella and isolates of Campylobacter from its
microbiological baseline data collection surveys. APHIS contributes
isolates from clinically ill animals and isolates from healthy animals
on farms. And, ARS conducts all testing and analysis of isolates
collected by USDA. The impact of NARMS has been to assist the FDA in
regulatory decision making on animal antimicrobial drugs, practitioners
on prudent use practices, and commodity organizations on quality
improvement.
In addition, APHIS has been collecting an increasing amount of data
on production practices and samples containing bacteria that have been
used to evaluate levels and impacts of antimicrobial use on livestock
operations throughout the United States. This data and the samples are
collected through the National Animal Health Monitoring System (NAHMS),
which conducts national studies on the health and health management of
United States domestic livestock and poultry populations. Bacterial
isolates gathered via NAHMS have been tested for antibiotic resistance
and included in the NARMS. The data collected yielded information on,
among other things, the types of antimicrobials used to treat various
common diseases in animal populations, how producers decide to treat
and what to treat with, how antimicrobial drugs are delivered to the
animals (via feed, water, or parenterally), and primary influencers on
the antimicrobial drug decision-making process. All of these factors
are critical to understanding the ways to optimize antimicrobial drug
use in animal populations.
APHIS, in collaboration with ARS, has also been collecting samples
to be cultured for bacteria as part of the NAHMS program, which are
subsequently evaluated for antimicrobial drug resistance as part of the
NARMS program. These studies provide information on the extent of
antimicrobial drug resistance among potential foodborne pathogens and
commensal organisms in livestock populations. Such information is
critical to risk assessments that evaluate the potential for transfer
of the resistant organism or resistance determinants through the food
chain. To date, the NAHMS program has collected antimicrobial drug use
and antimicrobial drug resistance data from 11 studies conducted
between 1994 and 2008.
Finally, in 2003, APHIS, ARS, and FSIS undertook a pilot project
that was designed to complement the NARMS and the NAHMS. The mission of
the Collaboration in Animal Health and Food Safety Epidemiology
(CAHFSE) was to monitor bacterial resistance to antimicrobial drugs on
farms over time and to evaluate the potential for resistant organisms
to persist in food products from animals from the farms under study.
Health and health management data were collected on the same operations
where repeated samples were collected over time. The CAHFSE project was
concluded in 2005.
In addition to the data collection and surveillance activities that
we are involved in, I would also like to mention two additional
activities that other USDA agencies participate in with respect to the
use of antibiotics in livestock: (1) Research and (2) prevention and
control.
In terms of research, ARS conducts hypothesis-driven research on
various topics relevant to use of antibiotics in livestock. This
includes research on the mechanisms of resistance development and
transfer of resistance genes; the potential mitigation for resistance
alternatives for antibiotic use in livestock; and alternatives to
antibiotics for subtherapeutic use and potential interventions for
foodborne pathogens that could affect resistance development. ARS also
develops technologies for the detection and characterization of
antibiotic resistance genes in foodborne pathogens, such as Salmonella,
Campylobacter, and E. coli.
In addition to ARS' research, a growing segment of CSREES' directed
funding had been dedicated to research on antimicrobial resistance.
from 1999-2008 there have been over thirty research, education and
extension competitive grants funded by CSREES in the area of antibiotic
resistance. The competitive grants, totaling over $17 million, were
funded primarily through the National Integrated Food Safety
Initiative, the National Research Initiative's (NRI) Epidemiological
Approaches for Food Safety, and the NRI Microbiological Approaches for
Food Safety; three flagship competitive grant programs administered by
CSREES. These grants were funded at various land grant universities,
professional societies, and other 4 year universities throughout the
country. The research focuses on a variety of foodborne pathogens as
they relate to antimicrobial/antibiotic resistance including Listeria
monocytogenes, Salmonella, E. coli, E. coli O157:H7, and Campylobacter.
Many of these studies are ongoing.
Prevention and control is an area of emphasis within USDA, both
domestically and internationally. On the domestic front, I would like
to highlight that, while the FDA regulates the use of drugs given to
food animals--including determining what drugs are permitted, what they
can be used for, and setting the tolerance levels for those drugs in
food animal tissues--FSIS is responsible for verifying the tolerance
levels for antibiotics set forth by FDA. To accomplish this, FSIS
collects samples of meat, poultry, and egg products at federally-
inspected establishments and analyzes these samples at FSIS
laboratories for chemical residues of veterinary drugs, among other
things.
Since 1967, FSIS has administered the National Residue Program
(NRP) to collect data on chemical residues in domestic and imported
meat, poultry, and egg products. The NRP is designed to provide a
structured process for identifying and evaluating compounds of concern
by production class, statistical analyses of compounds of concern,
appropriate regulatory follow-up of reports of violative tissue
residues, and collection, analyses, and reporting of the results of
these activities. When a violation of tolerance levels is found, FSIS
notifies FDA of the violation and assist in obtaining the names of
producers and other parties involved in offering animals for sale.
Internationally, USDA has also taken an active role in the
development of harmonized approaches and guidance on the use of
antibiotics. For example, representatives from the USDA, including ARS
and FSIS, are part of the ad hoc Intergovernmental Task Force on
Antimicrobial Resistance that was established by the twenty-ninth
Session of the Codex Alimentarius Commission. Its mandate is to develop
science-based guidance, taking full account of its risk analysis
principles and the work and standards of other relevant international
organizations, such as FAO, WHO, and OIE. The intent of this guidance
is to assess the risks to human health associated with the presence in
food and feed including aquaculture and the transmission through food
and feed of antimicrobial resistant microorganisms and antimicrobial
resistance genes and to develop appropriate risk management advice
based on that assessment to reduce such risk. The first session of the
Task Force was held in October 2007. The session was very productive
and resulted in the development of three project documents on risk
assessment, risk management and risk profiling based upon project
proposals submitted in response to the Circular Letter request for
proposals for new work. The next session is scheduled for this fall.
Conclusion
As the comments above indicate, we have made tremendous progress in
collaborating with our partners in the U.S. Government and industry
that have a stake in protecting public and animal health. Expanding
current partnerships with the livestock industry, as well as other
global and domestic stakeholders, will continue to be critical in
realizing advances of animal health within the livestock industry and
ensuring the health of our nation's domestic animal resources.
The Chairman. Well, thank you, Dr. Clifford, and I think we
will go ahead and ask Dr. Dunham to share, and then we will
come to questions following that.
But before Dr. Dunham delivers her testimony on behalf of
the Food and Drug Administration, I feel it necessary to
express a concern and frustration with the FDA that I have.
This hearing was originally planned for June 24 but had to be
postponed because we couldn't get a witness from the Center for
Veterinary Medicine. It is my full belief that someone from the
CVM, Center for Veterinary Medicine, would be the most
qualified to discuss advances in animal health within the
livestock industry, hence the title of this hearing. Today the
FDA has provided us with such a witness. However, in comparing
the testimony that was delivered by Dr. Linda Tolson on June 24
to the Senate Health Committee and the testimony delivered
today by Dr. Dunham, they seem to be the same. The testimony
spends nearly 95 percent of its time talking about public
health and completely ignores the topic of the hearing of
advances in animal health within the livestock industry. Now, I
understand the FDA has a message they want to get across but
not taking the subject of this hearing seriously is a concern.
Dr. Dunham, please begin when you are ready.
STATEMENT OF BERNADETTE DUNHAM, D.V.M., Ph.D.,
DIRECTOR, CENTER FOR VETERINARY MEDICINE, FOOD AND DRUG
ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ROCKVILLE, MD
Dr. Dunham. Thank you very much. Good morning, Mr.
Chairman, Members of the Subcommittee. I am Dr. Bernadette
Dunham, Director of the Center for Veterinary Medicine at the
Food and Drug Administration. Thank you for the opportunity to
discuss FDA's role with regard to antimicrobial resistance.
Preserving the effectiveness of existing antimicrobial
drugs, and encouraging the continued development of new ones,
are vital to protecting human and animal health against
infectious microbial pathogens. Approximately two million
people acquire bacterial infections in U.S. hospitals each year
and 90,000 die as a result. About 70 percent of those
infections are resistant to at least one drug. The trends
towards increasing numbers of infections and increasing drug
resistance show no sign of abating. Resistant pathogens lead to
higher healthcare costs because they often require more
expensive drugs and extended hospital stays. Resistant
infections impact clinicians practicing in every field of
medicine, including veterinarians.
The problem is not limited to hospitals or traditional
healthcare settings. Community-acquired infections are also
frequently resistant to multiple antimicrobial drugs such as
community-acquired methicillin resistant Staphylococcus aureus,
common respiratory pathogens including Streptococcus
pneumoniae, and gram-negative bacilli, which can affect humans
through contaminated food.
Many factors contribute to the spread of antimicrobial
resistance. In some cases, doctors prescribe antimicrobials too
frequently or inappropriately. Sometimes patients do not
complete the prescribed course of an antimicrobial, making it
more likely that surviving microbes will develop resistance.
Antimicrobial use in animals may contribute to the emergence of
resistant microorganisms that can infect people. Through
international trade and travel, resistant microbes can spread
quickly worldwide.
Antimicrobial agents have been used in human and veterinary
medicine for more than 50 years with tremendous benefits to
both human and animal health. However, after several decades of
successful antimicrobial use, we continue to see the emergence
of multi-resistant bacterial pathogens which are less
responsive to therapy. The emergence of antimicrobial resistant
bacterial populations is a complicated phenomenon and is
attributed in part to the combined impact of the various uses
of antimicrobial drugs in both humans and animals.
FDA co-chairs, along with the Centers for Disease Control
and Prevention and the National Institutes of Health, the U.S.
Interagency Task Force on Antimicrobial Resistance, which was
created in 1999 to develop a national plan to combat
antimicrobial resistance. In 2001, the Task Force published the
Public Health Action Plan to Combat Antimicrobial Resistance.
The Action Plan provides a blueprint for specific coordinated
Federal actions to address the emerging threat of antimicrobial
resistance. It reflects a broad-based consensus of Federal
agencies, which was reached with input from state and local
health agencies, universities, professional societies,
pharmaceutical companies, healthcare delivery organizations,
agricultural producers, consumer groups and other stakeholders.
The Action Plan has four major components: surveillance,
prevention and control, research, and product development.
Since 1996, FDA has actively addressed the issue of
antimicrobial resistance. For example, FDA's Center for
Veterinary Medicine is addressing potential human health risks
associated with the use of antimicrobial drugs in food-
producing animals. As part of the new animal drug approval
process, CVM developed and implemented an approach for
assessing antimicrobial resistance concerns associated with the
use of antimicrobial drugs intended for use in food-producing
animals. This approach uses risk assessment methodologies to
assess the potential human health impact from the proposed
antimicrobial use in animals and outlines risk management
strategies that may be applied. CVM is also applying the basic
principles of this approach to an ongoing review of currently
approved antimicrobial drugs. CVM believes that, while these
potential public health concerns must be addressed, it is
critical that veterinarians continue to have access to
effective antimicrobial drugs for the treatment, control and
prevention of disease in animals.
Other key components of CVM's strategy for addressing
antimicrobial resistance include robust research and monitoring
programs, as well as educational outreach activities. CVM is
actively conducting research to advance our understanding of
antimicrobial resistance mechanisms and to support our
regulatory decisions. CVM is the lead coordinator of the
National Antimicrobial Resistance Monitoring System, referred
to as NARMS. It is a multifaceted monitoring system that takes
advantage of the expertise and resources of a number of Federal
agencies and state public health laboratories. NARMS data
provide regulatory officials and the veterinary medical
community with critical information to help assess the risk
associated with antimicrobial use in food animal production.
CVM continues to collaborate with veterinary and animal
producer associations to develop and distribute guidelines on
the judicious use of antimicrobial drugs in food-producing
animals.
FDA'S other Centers are also actively working on
antimicrobial resistance. FDA's Center for Drug Evaluation and
Research has launched several initiatives to address
antimicrobial resistance, including regulating drug labels,
emphasizing the prudent use of systemic antibacterial drugs in
humans, and revising its guidance to industry on the
development of drugs for the treatment of bacterial infections.
FDA's Center for Biologics Evaluation and Research is
focused on the development and continued availability of
effective vaccines. Prevention of infections through the use of
vaccines has markedly decreased antimicrobial resistance by
reducing or nearly eliminating some types of infections.
Vaccines also contribute to the control of resistance by
reducing the need for antimicrobials.
In addition, development of increasingly sensitive
diagnostic assays for detection of resistance allows for
rational, targeted antibiotic use. FDA's Center for Devices and
Radiological Health leads several efforts to clarify regulatory
requirements to both industry and the scientific community on
clearance of diagnostic tests for use in antimicrobial
resistance initiatives.
In conclusion, I would like to mention that USDA and FDA
are cosponsoring a meeting this afternoon to discuss agenda
items and to present draft U.S. positions on them for the
upcoming second session of the Codex ad hoc Intergovernmental
Task Force on Antimicrobial Resistance to be held in Korea,
October 20 through 24, 2008. The public meeting will be held at
our Rockville facility in Maryland between 1 and 3 p.m. this
afternoon. The antimicrobial resistance task force was
established in 2006 to develop science-based guidance to be
used to assess the risks to human health associated with the
presence in food and feed, including aquaculture, and the
transmission through food and feed of antimicrobial resistance
microorganisms and genes. FDA will continue to work with
Federal, state, local and foreign government officials, medical
professionals including the veterinary community, the regulated
industry and all of our FDA stakeholders in developing sound
strategies to address and advance both human and animal health.
Thank you for the opportunity to discuss FDA's role with
regard to antimicrobial resistance, and I would be happy to
answer any of your questions.
[The prepared statement of Dr. Dunham follows:]
Prepared Statement of Bernadette Dunham, D.V.M., Ph.D., Director,
Center for Veterinary Medicine, Food and Drug Administration, U.S.
Department of Health and Human Services, Rockville, MD
Introduction
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Bernadette Dunham, D.V.M., Ph.D., Director of the Food and Drug
Administration's (FDA or the agency) Center for Veterinary Medicine
(CVM), which is a part of the Department of Health and Human Services
(HHS). Thank you for the opportunity to discuss FDA's role with regard
to antimicrobial resistance.
Preserving the effectiveness of current antimicrobials, and
encouraging the continued development of new ones, are vital to
protecting human and animal health against infectious microbial
pathogens. Approximately two million people acquire bacterial
infections in U.S. hospitals each year, and 90,000 die as a result.
About 70 percent of those infections are associated with bacterial
pathogens displaying resistance to at least one antimicrobial drug. The
trends toward increasing numbers of infection and increasing drug
resistance show no sign of abating. Resistant pathogens lead to higher
health care costs because they often require more expensive drugs and
extended hospital stays. The problem is not limited to hospitals.
Resistant infections impact clinicians practicing in every field of
medicine, including veterinarians. Community-acquired infections are
also frequently resistant to multiple antimicrobial drugs, such as
community-acquired methicillin-resistant Staphylococcus aureus (CA-
MRSA), common respiratory pathogens including Streptococcus pneumoniae,
and gram-negative bacilli, which can infect humans through contaminated
food.
In my testimony, I will provide background information on
antimicrobial resistance, discuss FDA's involvement with the
Interagency Task Force on Antimicrobial Resistance, and describe FDA's
actions to combat resistance and promote product development.
Background
Antimicrobial drugs are used to treat infections caused by
microorganisms. The term ``antimicrobial'' refers broadly to drugs with
activity against a variety of microorganisms including bacteria,
viruses, fungi, and parasites (such as malaria). The term
``antibacterial'' refers to drugs with activity against bacteria in
particular. Another term commonly used to describe an antibacterial
drug is ``antibiotic.'' This term refers to a natural compound produced
by a fungus or another microorganism that kills bacteria that cause
disease in humans or animals. Some antibacterial drugs are synthetic
compounds; i.e., they are not produced by microorganisms. Though these
do not meet the technical definition of antibiotics, they are referred
to as antibiotics in common usage.
Antimicrobial resistance is the ability of bacteria or other
microbes to resist the effects of a drug. Antimicrobial resistance
occurs when bacteria change in some way that reduces or eliminates the
effectiveness of drugs, chemicals, or other agents designed to cure or
prevent infections.
Many factors contribute to the spread of antimicrobial resistance.
In some cases, doctors prescribe antimicrobials too frequently or
inappropriately. Sometimes patients do not complete the prescribed
course of an antimicrobial, making it more likely that surviving
microbes will develop resistance. Antimicrobial use in animals may
contribute to the emergence of resistant microorganisms that can infect
people. Through international trade and travel, resistant microbes can
spread quickly worldwide.
Antimicrobial agents have been used in human and veterinary
medicine for more than 50 years, with tremendous benefits to both human
and animal health. Many infections that were fatal, or left individuals
with severe disabilities, are now treatable or preventable. However,
because resistance to antimicrobial drugs is expected to occur with
their use, it is essential that such drugs be regulated and used
judiciously to delay the development of resistance. Misuse and overuse
of these drugs contribute to an even more rapid development of
resistance. After several decades of successful antimicrobial use, we
have seen and continue to see the emergence of multi-resistant
bacterial pathogens, which are less responsive to therapy.
Antimicrobial-resistant bacterial populations are emerging because of
the combined impact of the various uses of antimicrobial drugs,
including their use in humans and animals. All of these pathways are
not yet clearly defined or understood.
New classes or modifications of older classes of antimicrobials
over the past 6 decades have been matched slowly but surely by the
systematic development of new bacterial resistance mechanisms. As of
today, antimicrobial resistance mechanisms have been reported for all
known antibacterial drugs that are currently available for clinical use
in human and veterinary medicine. In some cases, strains have been
isolated that are resistant to multiple antibacterial agents.
U.S. Interagency Task Force on Antimicrobial Resistance
To address these challenges, the U.S. Interagency Task Force on
Antimicrobial Resistance was created in 1999 to develop a national plan
to combat antimicrobial resistance. FDA co-chairs the task force, along
with the Centers for Disease Control and Prevention (CDC) and the
National Institutes of Health (NIH).
The Task Force also includes the Agency for Healthcare Research and
Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), the
Health Resources and Services Administration (HRSA), the Department of
Agriculture (USDA), the Department of Defense, the Department of
Veterans Affairs, and the Environmental Protection Agency. In 2001, the
U.S. Agency for International Development joined the Task Force to help
address global antimicrobial resistance issues.
Public Health Action Plan To Combat Antimicrobial Resistance
In 2001, the Task Force published the ``Public Health Action Plan
to Combat Antimicrobial Resistance'' (Action Plan). The Action Plan
provides a blueprint for specific, coordinated Federal actions to
address the emerging threat of antimicrobial resistance. It reflects a
broad-based consensus of Federal agencies, which was reached with input
from consultants from state and local health agencies, universities,
professional societies, pharmaceutical companies, healthcare delivery
organizations, agricultural producers, consumer groups, and other
members of the public.
The Action Plan has four major components: surveillance, prevention
and control, research, and product development. Highlights of the
Action Plan include:
Surveillance. Information and statistics about the emergence
and spread of resistant microbes and the use of antimicrobial
drugs can help experts interpret trends and identify strategies
to prevent or control antimicrobial resistance. CDC is working
with state health departments and other Task Force members to
design and implement a strategy to coordinate national,
regional, state, and local surveillance efforts. In addition,
FDA, CDC, and USDA developed and expanded systems to monitor
patterns of antimicrobial resistance among foodborne bacteria
in human medicine, in agriculture, and in retail meat.
Prevention and Control. Research shows that controlling the use
of antibacterial drugs can help reduce the incidence of
antimicrobial resistance. In 2003, FDA partnered with CDC on
its launch of its Get Smart: Know When Antibiotics Work
campaign. The goal of the campaign is to educate consumers and
healthcare professionals on the appropriate use of antibiotics.
In partnership with doctors and other medical professionals,
CDC has developed clinical guidelines for health professionals
on how best to use antimicrobials and supports pilot projects
to identify effective strategies to promote appropriate
antimicrobial drug use. FDA has promulgated labeling
regulations for the appropriate use of systemic antibacterial
drugs in humans. CVM has developed, in conjunction with
stakeholders, in-depth antimicrobial prudent use principles for
beef, dairy, swine, poultry, and more recently, aquatic
veterinarians.
Measures that reduce the need for antimicrobial use also serve
to reduce the emergence of antimicrobial-resistant
microorganisms. Prevention of bacterial infections through the
use of vaccines has effectively eliminated or markedly
decreased the problem of resistance in organisms such as
Haemophilus influenzae type b (virtually eliminated in the U.S.
while still a problem in other parts of the world) and
Streptococcus pneumoniae, also known as pneumococcus. Published
research has confirmed that the latter pneumococcal vaccine has
lowered common infections that are often treated with
antimicrobials. Prevention of viral infections through the use
of vaccines can also indirectly help reduce antibiotic use and
minimize the emergence of antibiotic-resistant microorganisms.
For example, viral infections, such as respiratory infections
due to influenza, often lead to unnecessary antimicrobial use
and are sometimes complicated by serious secondary infections
caused by bacteria such as staphylococcus or pneumococcus. In
addition, development of increasingly sensitive diagnostic
assays for detection of resistance allows for rational targeted
antimicrobial use.
Research. The Action Plan promotes expanding existing research
in antimicrobial resistance and related fields in an effort to
improve treatments and outcomes. NIH is leading a team of
agencies to provide the research community with new information
and technologies, including genetic blueprints for various
microbes, to identify targets for desperately needed new
diagnostics, treatments, and vaccines to combat the emergence
and spread of resistant microbes. NIH supports clinical studies
to test new antimicrobials and novel approaches to treating and
preventing infections caused by resistant pathogens. NIH also
continues to support and evaluate the development of new rapid
diagnostic methods related to antimicrobial resistance, in
conjunction with FDA's Center for Devices and Radiological
Health (CDRH). In addition, AHRQ funds various studies on the
use of antimicrobial drugs and antimicrobial resistance,
including ongoing research on reducing unnecessary prescribing
of antimicrobials to children. FDA's Center for Biologics
Evaluation and Research (CBER) conducts research that
facilitates vaccine development for diseases in which
resistance is an issue, such as malaria, staphylococcus (MRSA),
and enteric diseases.
Product development. As antimicrobial drugs lose their
effectiveness, new products must be developed to prevent,
rapidly diagnose, and treat infections. The priority goals and
action items in the product development focus area of the
Action Plan address ways to:
Ensure researchers and drug developers are informed of
current and projected gaps in the arsenal of antimicrobial
drugs, vaccines, and diagnostics, and of potential markets
for these products;
Stimulate development of priority antimicrobial products
for which market incentives are inadequate, while fostering
their appropriate use;
Optimize the development and use of veterinary drugs and
related agricultural products that reduce the transfer of
resistance to pathogens that can infect humans; and
Facilitate development of effective prophylactic vaccines:
in particular, focusing on vaccines against microbes that
are known to develop antimicrobial resistance (e.g., MRSA),
thereby reducing the need for antimicrobials and the
occurrence of antimicrobial resistant strains.
The task force is currently updating the Action Plan for the next 5
years.
FDA Accomplishments on Antimicrobial Resistance
Since 1996, FDA has actively addressed the issue of antimicrobial
resistance. As an agency composed of several product centers, FDA has
addressed antimicrobial resistance through a variety of initiatives,
primarily through four key areas: surveillance, product development,
education, and research.
Surveillance: Monitoring and surveillance of antimicrobial
resistance and then promptly and effectively responding to
current threats from drug resistance.
Product Development: Facilitating and encouraging
development and appropriate use of products, including new
drugs and vaccines, and improved, more timely tests for
infectious diseases.
Education: Facilitating the safe and effective use of
antimicrobials and thus prolonging the life of these products
by helping improve the quantity and quality of information
available to consumers and health professionals regarding
antimicrobial resistance and principles of appropriate usage.
In addition, FDA has an important role in informing the public
and healthcare professionals both through educational outreach
and by assuring useful and accurate product labeling and
appropriate marketing.
Research: Maximizing and coordinating FDA's scientific
research to address needs in antimicrobial resistance.
Specific activities by the various Centers within FDA include the
following:
Center for Veterinary Medicine (CVM)
CVM is addressing potential human health risks associated with the
use of antimicrobial drugs in food-producing animals. CVM's approach
uses risk assessment methodologies to quantify the human health impact
from antimicrobial use in animals, in conjunction with robust
monitoring, research, and risk management. CVM is actively conducting
research to advance our understanding of antimicrobial resistance
mechanisms and to support our regulatory decisions. The agency also
continues to participate in public meetings with stakeholders to
provide educational outreach activities and to strengthen and promote
science-based approaches for managing the potential human health risks
associated with the use of antimicrobial drugs in food-producing
animals.
One of the key components of CVM's strategy to assess relationships
between antimicrobial use in agriculture and subsequent human health
consequences is the National Antimicrobial Resistance Monitoring System
(NARMS). CVM is the lead coordinator of NARMS. NARMS is a multi-faceted
monitoring system that takes advantage of the expertise and resources
of a number of Federal agencies and state public health laboratories.
NARMS data provide regulatory officials and the veterinary medical
community with critical information to help assess the risk associated
with antimicrobial use in food animal production.
As part of the new animal drug approval process, CVM developed and
implemented an approach for assessing antimicrobial resistance concerns
associated with the use of antimicrobial drugs intended for use in
food-producing animals. This approach uses risk assessment
methodologies to assess the potential human health impact from the
proposed antimicrobial use in animals and outlines risk management
strategies that may be applied. In 2003, FDA published Guidance for
Industry #152 (``Evaluating the Safety of Antimicrobial New Animal
Drugs with Regard to their Microbiological Effects on Bacteria of Human
Health Concern''). Guidance #152 provides recommendations to drug
sponsors on the use of a qualitative risk assessment approach for
evaluating the likelihood that an antimicrobial drug used to treat a
food-producing animal may cause an antimicrobial resistance problem in
humans. The risk assessment approach recommended in the guidance
considers a broad set of information, including the importance of the
drug in question to human medicine. This information is collectively
considered in determining whether the proposed antimicrobial product
will pose a risk to public health.
CVM is also applying the basic principles of this approach to an
ongoing review of currently approved antimicrobial drugs. While
potential public health concerns must be addressed, it is critical that
veterinarians continue to have access to effective antimicrobial drugs
for the treatment, control, and prevention of disease in animals.
CVM continues to collaborate with veterinary and animal producer
associations to develop and distribute guidelines on the judicious use
of antimicrobial drugs in food-producing animals.
Center for Drug Evaluation and Research (CDER)
CDER has launched several initiatives to address antimicrobial
resistance. Through CDER's initiatives, FDA has issued drug labeling
regulations emphasizing the prudent use of systemic antibacterial drugs
in humans. The regulations encourage healthcare professionals to
prescribe these antibacterial drugs only when clinically necessary and
to counsel patients about the proper use of such drugs and the
importance of taking them as directed.
Over the last several years, CDER has been evaluating the design of
clinical trials that are used to study the safety and efficacy of drugs
for the treatment of a variety of infections. CDER recognizes the
importance of ensuring that antibacterial drugs are approved based on
sound, informative clinical trials, because the clinical use of
marginally effective antimicrobials can contribute to the development
of antimicrobial resistance. For milder infections that are often self-
resolving over time, we are recommending different types of studies
than what were used in the past. The agency is doing this in order to
have studies that have the capacity to provide informative data to
assess an antimicrobial drug's effects in these milder conditions. It
is essential that clinical trials evaluating a new drug be performed in
a manner that allows for assessment of the benefits and the risks of
the drug in the condition under study. A better assessment of the
benefits that a drug may provide and balancing these benefits with
risks should provide better quality information on antimicrobial drugs
to foster appropriate use and ideally reduce inappropriate use that is
also contributing to the development of resistance.
To that end, CDER has been revising its guidance to industry on the
development of drugs for the treatment of bacterial infections. Since
October 2007, CDER has issued four such guidance documents. In January
of this year, FDA co-sponsored a workshop with the Infectious Diseases
Society of America to discuss clinical trial designs for community
acquired pneumonia (CAP). The agency also convened an advisory
committee meeting in April 2008 to get additional advice and the agency
is now writing a draft guidance document that will provide the agency's
thinking on informative trial designs in CAP. By providing these draft
guidance documents on developing drugs for these conditions we have
provided some clarity on the types of study designs that will be
informative in these conditions.
Most of the discussion of drug development has focused on
resistance in common bacterial infections, but resistance is also a
problem in conditions such as tuberculosis (TB), fungal infections, and
malaria. CDER has participated in a working group with other
representatives from FDA and the European Medicines Agency to discuss
strategies for developing drugs for TB. CDER also published a draft
guidance document describing approaches to the development of drugs for
malaria in June of 2007.
Appropriate use of antimicrobial drugs is guided not only by
understanding the safety and effectiveness of risks and benefits of
these drugs, but also by having information on whether a particular
drug is active against a patient's infection when culture results are
available. Laboratory testing to assess whether a bacterial isolate is
``susceptible'' to a particular antimicrobial drug can provide such
information. There are a number of antibacterial drug labels that are
in need of updating of the information on susceptibility testing. FDA
recently published a draft guidance document on ``Updating Labeling for
Susceptibility Test Information in Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility Testing Devices'' (published June
2008). This draft guidance, in compliance with section 1111 of the Food
and Drug Administration Amendments Act of 2007 (FDAAA), describes
options for updating the antibacterial susceptibility testing
information in antibacterial drug product labeling and we believe could
facilitate the timely updating of this information.
Section 1112 of FDAAA requires FDA to convene a public meeting to
consider ``which serious and life threatening infectious diseases, such
as diseases due to gram-negative bacteria and other diseases due to
antibiotic-resistant bacteria, [would] potentially qualify for
available grants and contracts under section 5(a) of the Orphan Drug
Act . . . or other incentives for development.'' In compliance with
Section 1112 of FDAAA, FDA held a public hearing on April 28, 2008, to
discuss, in part, potential incentives to encourage pharmaceutical
companies to develop new antimicrobial drugs.
Center for Biologics Evaluation and Research (CBER)
Research and regulatory efforts have contributed to the development
and continued availability of effective vaccines which have eliminated
or markedly decreased antimicrobial resistance by reducing or even
nearly eliminating some types of infections. Other vaccines contribute
by reducing the need for use of antimicrobials. CBER has initiated a
new research program to facilitate vaccine development to prevent MRSA
and has ongoing research programs to foster the development of vaccines
to prevent other frequent infectious diseases problems such as
Salmonella or E. coli gastroenteritis, and TB, as multidrug-resistance
has emerged as a national and international threat to health. In
addition, CBER works with sponsors to develop safe and effective
vaccines against emerging infectious diseases problems. Additional
efforts at CBER address new diagnostic tests and evaluation of emerging
technologies and test kits for detecting bacteria as it relates to
transfusion medicine, mechanisms of resistance, alternative therapies
for highly resistant organisms, and regulatory pathways to assess the
potential value of probiotics to help reduce the development and spread
of antimicrobial-resistant bacteria.
Center for Devices and Radiological Health (CDRH)
CDRH leads several efforts to clarify regulatory requirements to
both industry and the scientific community on clearance of diagnostic
tests for use in antimicrobial resistance initiatives. For example,
CDRH assisted device manufacturers to get an alternative method for
detecting vancomycin resistant Staphylococcus aureus to market and
assured timely introduction of this critically important new product
through use of its expedited review process. CDRH has published
guidance documents to ensure the safe and effective use of in vitro
diagnostics for detecting novel influenza A or A/B viruses from human
specimens. CDRH recently cleared a new assay developed by CDC for the
detection of human infection with H5 Avian Influenza virus. CDRH also
recently cleared a rapid test for confirming methicillin resistant
Staphylococcus aureus, a rapid DNA test for detecting Group B
Streptococcus in pregnant women, and a rapid test for detecting Shiga
toxins one and two produced by E. coli in stool specimens to aid in the
diagnosis of diseases caused by enterohermorrhagic E. coli infections.
Conclusion
In conclusion, I would like to note that USDA and FDA are
cosponsoring a meeting this afternoon to discuss agenda items and to
present draft U.S. positions on them for the upcoming second session of
the Codex ad hoc Intergovernmental Task Force on Antimicrobial
Resistance (AMR) to be held in Korea, October 20-24, 2008. The public
meeting will be held at CVM's Rockville, Maryland, offices between 1:00
and 3:00 p.m. today. This AMR Task Force was established in 2006 to
develop science-based guidance to be used to assess the risks to human
health associated with the presence in food and feed, including
aquaculture, and the transmission through food and feed of
antimicrobial resistant microorganisms and genes. FDA will continue to
work with Federal, state, local and foreign government officials,
medical professionals including the veterinary community, the regulated
industry and all of FDA's stakeholders, in developing sound strategies
to address and advance both human and animal health.
Thank you for the opportunity to discuss FDA's activities with
regard to antimicrobial resistance. I would be happy to answer any
questions.
The Chairman. Well, thank you very much. I appreciate you
being here and your statement.
In taking note of the written testimony presented by the
second panel, who will be talking to us shortly about their
concern about the importance of FARAD, as I stated earlier, on
July 10, Representative Hayes and I sent a letter to both USDA
and FDA stressing the importance of the program, and also to
provide emergency funding to keep the program operating. Over 2
months later, here we are with no response from either agency,
so what is the status of the funding for this program, either
of you?
Dr. Dunham. As you know, this program has actually been
based within USDA CSREES for a very long time. With the 2008
Consolidated Appropriations Act, USDA did not receive any
appropriated funds to support the FARAD program, and we are
currently working with a lot of the stakeholders to look at
some potential, alternative mechanisms that may be available to
assist with this program. I do agree that it is a very
important program, and we are certainly hoping to be able to
get back to you with some very positive results.
The Chairman. Dr. Clifford?
Dr. Clifford. Mr. Chairman, I have with me today Rob
Hedberg, the Acting Director for Legislative and Governmental
Affairs from CSREES, and I would ask that he respond to this
question.
The Chairman. Okay. State your name, please.
Mr. Hedberg. My name is Rob Hedberg, and again, I am Acting
Director of Legislative and Governmental Affairs for the USDA
Cooperative State Research, Education, and Extension Service.
Unfortunately, we do fully understand your concerns about the
FARAD program. We have been active in management of this
program for many years. We recognize the letter of the request
for $2.5 million to provide bridge funding for this program,
but the reality is that the program was last appropriated in
2006, and since then there were no funds provided in
appropriations in 2007 or 2008. It has been pointed out for
2008, funds were provided by both FDA and USDA CSREES to
provide just short of $1 million, which was bridge funding to
keep the doors open until now, but unfortunately, our situation
at USDA is, we do not have the funds available to continue
support of this program. If funds are appropriated for this
program, we would gladly continue our administration of it
through CSREES.
The Chairman. Well, I appreciate you saying that. Of
course, we are all aware that you have within the agency
transferred money around where you see priorities and so on. I
appreciate that, and I hope that we will get something that we
can share with the appropriate appropriators, if you will, a
play on words, regarding what you have just shared with us.
Thank you very much.
Mr. Hedberg. You are welcome. Thank you.
The Chairman. Another question, if I could. In the decade
that the National Antimicrobial Resistance Monitoring System,
NARMS, has been enacted, what have you learned about the scope
of antimicrobial resistance? How rapid has resistant bacteria
increased in agriculture?
Dr. Dunham. The NARMS program has been very effective and
helpful as we tried to follow this very complex issue--where do
you see and how do you see antimicrobial resistance developing.
This has allowed us to team with the CDC and USDA to take a
look at samples that have been taken from the slaughter
facilities; and to follow these through, as we do at FDA, to
take a look at the final retail meat products that are in the
market. From that, we have been able to, now--courtesy of the
technology and the DNA fingerprinting--indicate if we are
seeing any resistant serovars, specifically looking along the
lines of Salmonella and Campylobacter. As we are able to track
that, we can see if there are indications of some resistance
developing, and that allows us then to take a look in the
science to make new decisions as to how we may or may not take
action. So it has been very helpful and we are hoping to see
this expand. We had an external science board review recently
complete an overview of the NARMS and they were very impressed
and pleased with that, so we are hoping to see this grow. Thank
you, sir.
The Chairman. Thank you.
Dr. Clifford?
Dr. Clifford. Mr. Chairman, I definitely agree with Dr.
Dunham. These types of things are very useful. We need to use
appropriate science and collection of data to be able to make
decisions about animal health as well as human health and
public safety. So we find these types of things to be very
effective in helping address and answer these types of
questions that are before you.
The Chairman. Well, thank you, and before I ask Mr. Hayes
to participate, I think it is safe for me to say that you agree
that healthy animals produce healthy food. In your opinion,
does the Denmark case highlight the benefits of both
therapeutic and growth antibiotics? What comment might you make
about the Denmark example?
Dr. Clifford. I am sorry, Mr. Chairman. Could you repeat
that question, please?
The Chairman. In your opinion, does the Denmark case
highlight the benefits for both therapeutic and growth
antibiotics?
Dr. Clifford. Absolutely. It certainly does. We feel that
the therapeutic use of antibiotics is extremely important in
animal health as well as the prevention and the prophylactic
use of antibiotics.
Dr. Dunham. I think with the Denmark situation, we further
did see just how antibiotics are being used and the importance
of antibiotics to sustain the health of our animals. I think
part of what we saw was when there was a removal of the
antibiotics, the therapeutic need was clear. And the catch is,
what we are looking at is how a veterinarian will take a look
at the animals and be able to decide, from their own training
and understanding of disease, when to intervene to treat,
control and prevent disease, and that it is very important to
keep our animals healthy. I think what we saw in the long run
after the Denmark study was, at the time they did a complete
ban, it clearly showed us that the antibiotics were working to
address a pathogen and they ended up coming back with the
therapeutic use of that drug. At that time we probably saw just
where that was important. Weanling pigs, for example, will
outbreak with diarrheal disease if you are not able to
intervene and treat those animals.
The Chairman. Thank you. I will have some more questions,
but I would like to yield to Mr. Hayes.
Mr. Hayes. Thank you, Mr. Chairman.
Dr. Clifford, as you suggest, disease prevention is much
more economical than treatment. In the context of the debate
over the judicious use of animal health tools in livestock
production, would the Department support or oppose legislation
which arbitrarily prohibits the use of essential animal health
tools by veterinarians?
Dr. Clifford. The Department believes that, and APHIS--
actually I represent APHIS here today--would believe that it is
important, very important for veterinarians and animal health
professionals to have the opportunity to apply these drugs as
necessary for therapeutic and prophylactic use in the field. It
is extremely important, yes.
Mr. Hayes. So you would oppose a ban.
Dr. Dunham, in later testimony, Dr. Singer suggests that
the risk assessment process currently used by FDA should be
modified to take into consideration the impact of implementing
specific interventions to reduce human and animal health risk.
To what extent do you consider risk mitigation strategies when
conducting your assessment?
Dr. Dunham. When we go through our drug review approval
process, we are looking to ensure that that drug will be safe
and effective, and we look at the data that is given to us by
the companies to assess that. At the time that you are looking
at anything post our approval process, for example, if you were
to look at risk mitigation within a slaughter plant--what is
being used to handle the carcass, what is being used if you did
irradiation before you packaged the meat--any of those
interventions are something that would not be something we
could take a look at as we are looking from the pharmaceutical
company's review of data provided to us for the approval of
that drug to be used in the animal for safety and
effectiveness. We don't control those other interventions so it
makes it very difficult for us to assess that. So we come back,
first of all, with that product and the science that we look at
to determine safety and effectiveness of that product being
used in that animal. And for that reason, then we can approve
that product for its safety and effectiveness. Then we do a
post-surveillance monitoring of that afterwards to see if we
are having any adverse reaction in the animal, and at the same
time looking at any data to see, are we finding any problems
with resistance.
Mr. Hayes. I think that was a really good answer. I am not
sure so much depth that I can get it. To boil it down, do you
feel like the processes that we are using now are a reasonable
and safe way to address the issue of prevention versus
mitigation?
Dr. Dunham. Yes, sir. As we at the FDA are looking at that
product to determine if it is going to meet our approval
standards, then we do base all of that with our scientific
critique and review. I am very confident, by the time we do put
our stamp on it to say this drug is approved for that use in
that species and that indication, that yes, we are very happy
with that process.
Mr. Hayes. Thank you.
Dr. Clifford, would you agree?
Dr. Clifford. Yes, I do.
The Chairman. Thank you, Mr. Hayes.
The chair recognizes Mr. Kagen from Wisconsin for 5
minutes.
Mr. Kagen. Thank you, Mr. Chairman, and thank you both for
appearing here before us this morning, and Dr. Clifford, I want
to give you an opportunity here to identify, let me just assume
that you don't want Congress to begin to practice veterinary
medicine by dictating what drugs should or should not be used.
Would that be a fair assumption?
Dr. Clifford. Yes, Congressman, it would be. I would not
want that dictated by Congress. I think it is appropriate as
animal health officials that the veterinary professional who
has the knowledge and the skill sets to be able to apply
antimicrobials in an appropriate way and an appropriate use for
animal health.
Dr. Dunham. I think it is very true, the training that our
veterinarians go through to practice medicine, they are the
ones that you turn to. They are the ones that understand
disease process and then, based upon the products that are
approved, that they can reach for in their armamentarium, to be
able to appropriately use those is the way it should be. So
with the veterinarian's discretion, they are the ones that can
decide when to intervene, to treat, prevent or control a
disease.
Mr. Kagen. And I will agree with you to the extent that you
stay within veterinary medicine and don't go over to the human
side because my natural inclination is to disagree with that.
What would be the three most critical problems that you are
facing in APHIS that you think need to be addressed? If I just
was able to wave a wand or if my name was Secretary Hank
Paulson, I could come up with $2 billion, forget the money,
what are the three most critical problems that you are facing
in APHIS that you think need to be addressed? It is a softball
question. You didn't expect that.
Dr. Clifford. No, I really didn't.
Mr. Kagen. I have only got a couple minutes, so you have
thought about this for your whole career, now you are here,
your agency is counting on you right now, Dr. Clifford.
Dr. Clifford. Well, it would be, I think in three areas.
One, I think it is critically important that we use new
technology and techniques to help us address animal health
issues in this nation. I think it is important we be able to
move toward a system where we can effectively eliminate disease
or control disease through other methods other than massive
depopulation in the future. Because, for one, the cost to
taxpayers; two, really the waste of protein that that does. So
that is through the research and development of new technology.
Second, I think it is critically important as we look at
animal health threats and issues that we have good continuity
of operation planning within the United States so that we can
keep producers viable and healthy, even in the face of an
outbreak situation. So, that we can allow animals to move
safely through mitigation measures and good biosecurity.
Third, traceability, and that is part of our animal ID
program that we are moving forward in. Traceability is
critically important to animal health and to be able to
effectively eliminate disease quickly. Thank you.
Mr. Kagen. Dr. Dunham?
Dr. Dunham. Thank you. I would also agree. I think one of
the challenges we are facing now is being able to embrace the
exciting field of where we are going with our biotechnology.
Science is at the heart of everything we do for our decisions
and we need to embrace the new science, and at the same time
develop some new ways of intervening, as we just discussed, to
keep the health of both people and animals moving forward. New
technology will open those doors for us. Being able to adapt
that means we need to have an opportunity to sustain the
science and the research that is going to bring those to us. We
do the review, so it is what is coming in the pipeline. So
anything that continues to advance the research to allow our
companies, universities to break through into new technologies
and bring those forward to us is going to be very, very, very
helpful.
I think also we can try to harmonize. We talked earlier
that, internationally, we are meeting with Codex this
afternoon. We are one world, and we said before, people travel,
animals travel and microbes travel. The more that we are aware
of what is happening internationally, it is going to be
quintessential as we try to get our hands around these issues
because we don't know what is going to walk in the door.
Veterinary students used to have a textbook and be told if you
don't travel to country X, don't worry, you will never see this
disease. That is not true anymore. So we as the agencies have
to embrace the idea that what will be walking in our front door
could impact the health of people and animals. That would be
another venue of how we work internationally together. Also,
with regards to methodologies, how we get to a standardization,
where it is possible, that our labs can talk, not only within
the state but across the states, so we know what is moving in
the country, and we can really track appropriately. You are no
longer having to compare apples to oranges; you can compare
apples to apples. So all of that comes back down to a
combination of technologies.
Mr. Kagen. Thank you for your comments, and before I go too
far over, I just have to make a comment about the disinterest
of my constituents in northeast Wisconsin of being faced with
the possibility of paying for the inspection of the quality and
health of foreign food products that might be shipped into this
country. We don't want to have to pay for somebody else's
mistakes here, and along those lines, if I could just beg the
Chairman for a minute to get your comments on what your
agencies are doing to make sure that other countries who seek
to ship their product here are doing to move up to our quality.
Dr. Clifford. Congressman, at APHIS we have negotiations,
bilateral negotiations with countries with the movement of live
animals and animal products, and there are certain mitigations
and certifications that are required for the movement of those
products. Our agency as well as in cooperation with other
organizations and Customs and Border Protection are there to
assure that those products and animals that enter into the
United States meet those conditions.
Mr. Kagen. Does that mean that they are having anything to
do with our standards about the use of antibiotics?
Dr. Clifford. With regards to antibiotic use, I would have
to defer that to those that are authorized or have the
authority over that particular area. With our area though, they
have certain standards relative to disease issues and threats.
Dr. Dunham. Regarding again the harmonization that many of
us are looking at with VICH that we have similar to the human
side of ICH--where we understand what the review processes are
within other countries and how they go through to decide the
safety and effectiveness of the drugs that they approve and how
they are being utilized--that open dialog helps a tremendous
amount. Codex Alimentarius is one program that allows us to go
through that, take a look at MRLs within various drugs and now
most recently, as I mentioned, this afternoon there will be the
second follow-up of the Codex group taking a look specifically
at what countries are doing to address antimicrobial
resistance. So what are the standards, what are the
methodologies? The more we understand how each country is
approving and utilizing those drugs in the practice, in this
case, of agriculture, the more it will make it easy for us to
work together and have that transparency.
Mr. Kagen. Thank you very much. I look forward to working
with you and making certain that consumers have an easy way of
identifying what is in their food and where it comes from.
Thank you for your work.
I yield back my time.
The Chairman. Thank you, Mr. Kagen.
The chair recognizes the gentleman from Nebraska, Mr.
Smith, for 5 minutes.
Mr. Smith. Thank you, Mr. Chairman, and thank you to the
witnesses.
We know that the marketplace has high expectations and
therefore producers want to meet those expectations. Otherwise
they don't have a product that will sell and hopefully a
commensurate profit. As we do look at this, we know that some
groups are advocating a legislative ban on the use of
antimicrobials for growth promotion and feed efficiency. What
do you think would be the impact this legislative ban would
have on development of antimicrobial resistance, and what
impact would you believe the legislative ban would have on the
actual animal health?
Dr. Clifford. It would be a very devastating effect upon
animal health if we did not have the ability and the use of
antibiotics for therapeutic and prophylactic use to prevent a
number of diseases. So from an animal health perspective, this
is something that we would not support. This needs to be in the
hands of professionals and veterinary professionals within the
field to be able to handle it. We do agree that we need good
data to be able to do proper analysis with regards to
antibiotic resistance both in the protection of animal health
as well as human health. I think we should rely upon the
science to dictate the direction that we go versus legislation.
Mr. Smith. Dr. Dunham?
Dr. Dunham. We haven't taken any specific position on any
legislation, as you well know, but separate from all of that,
in general, it is absolutely true, with FDA having the
opportunity to do the scientific review of any of the products
coming through for us to look at to decide their safety and
effectiveness in animals, our standards are very high and we
hold to those. That being said, once a product has been
approved and you have that claim on the label indicating its
use--dosage, species, indication--the veterinarian is the one
who then takes hold of that and, with their training, is
therefore the capable person to indicate how to use that drug.
At the same time, that is what we do when we embrace the use,
the judicious use, of any antimicrobial. So there is an
appropriate workup to decide when to treat, prevent or control
a disease. This is done on a scientific basis and through the
training that the veterinarians have to do that.
Mr. Smith. Thank you very much. I will say that to be
honest with you, I think for humans sometimes, the use of
antibiotics and so forth might be a little overused and I say
that for myself personally, but I don't really go to the doctor
always looking for an antibiotic as often as it might be
offered. It had never crossed my mind to seek a legislative ban
on that because I might share some personal feelings about
that. But it does, I think, speak to the larger issue of what
the role of government is here, so I appreciate your input and
I yield back.
The Chairman. Thank you, Mr. Smith.
Dr. Dunham, I would like to pursue a couple more questions.
Would you please describe the process a food-animal drug must
go through before it can be used on the market, and if you can,
average how much time and money is invested?
Dr. Dunham. Yes, sir. A company will give us a product to
take a look at. We assess all the scientific information they
provide to determine the safety of that drug, the target-animal
safety, the effectiveness of that drug in that target animal.
We take a look at environmental impact. We take a look at the
chemistry and manufacturing surrounding that product to ensure
it is stable and does exactly what it is supposed to do. We
take a look at any toxicology that is involved, and when it is
for use in a food-producing animal, then we have to also take a
look at it with our human food safety group. They will then
take a look to decide, for example, would there be any
residues, and if so, what is an acceptable level, and that has
to be reviewed as well. And when we have done all of that, we
will then be able to decide if this product is safe and
effective. So there are multiple teams that get pulled together
in our Office of New Animal Drug Evaluation to take a look at
all aspects of that package in order to have all of those
various sections reviewed and completed before we can finally
say yes, this drug is approved. And it depends upon the drug,
depends upon the class, use, et cetera, as to how long that may
or may not take and the data sets that are being provided for
us to have that rigorous scientific review. So that is a very
short overview of the procedure that is required for them to go
through.
And as you hear on the human side or veterinary side, there
are a number of years that go into that when you are developing
the first molecule and bringing it all the way through to what
you can call molecules to miracles, when you have that drug in
hand to be able to effectively use that to prevent or treat
that disease that you are looking at. And companies then take
all of that under consideration when they are developing that
product and give us the data sets that we look at. If we have
questions, if there is further data that we need, we dialogue
that with the company and they usually work very well with us
so that we absolutely make sure the i's are dotted and t's are
crossed. So we have the confidence when we finally say it is
approved that we can follow that through. Then we follow with
post-surveillance to see whether or not, when it is finally out
being utilized, we are seeing any adverse effects. At that
time, based upon what we are seeing in the science again, we
can take a look and make any potential changes to that label, a
warning box or make any further changes that are appropriate.
It is all based on the science and the data that we collect as
we monitor this.
The Chairman. That is pretty extensive. Do you have some
kind of an idea what it costs to do this, maybe compare what it
costs to get a drug on the market for human use?
Dr. Dunham. I wouldn't be able to give you a direct cost of
that. I think each one depends--the pharmaceutical companies
usually have a pretty good idea and they can tell you how much
it costs them to do the research, the developing, gathering the
data that they then give to us for that review. I think those
numbers are available but I can't give them to you off the top
of my head. I would be happy to obtain that information and
submit that to you.
The Chairman. Okay. Is it true that if a food-animal drug
has any risk to humans, the drug can't be used?
Dr. Dunham. No. I think we go through the review process to
assess how that drug will be used and we are able to decide
limitations if that is appropriate, if we decide that. We do
have, as you know, a guidance that has been developed. It is
referred to as Guidance #152. And that allows us to take a look
at a lot of the risk issues and it is one of our tools that can
be utilized when we are going to be looking at the development
and approval of an antimicrobial. At that point we do have a
scenario, working with our counterparts in human medicine as
well, to take a look at those drugs' very important use in
humans. Sometimes that will be a limitation as to whether or
not we have a green light to say whether that same drug can be
used or not used in animal medicine. But for the most part,
there are opportunities to take a look at this and decide when
and where and how much we can use that drug for an approved use
in animals, and that has been a very good guidance. It has
worked very well and we have had a chance to have advisory
committees work with us as well on that.
The Chairman. In your testimony, you outline human public
health numbers. How many livestock bacterial infections are
there in the United States?
Dr. Dunham. I don't think I have that on the tip of my
tongue, but I could certainly take a look and work with John
and get some information back to you.
Dr. Clifford. I was just going to say, Mr. Chairman, we
will work with FDA to provide that for the record.
The Chairman. Okay. I appreciate that. All right. What are
the four areas that FDA approves antimicrobial use in food
animals? I understand there are four areas that FDA approves
antimicrobial use in food animals.
Dr. Dunham. They, again, are based upon the claim that is
being requested by the company. We would be looking to see what
the disease is that is being requested for us to take a look
at, and approve that product to be utilized. I am not sure if I
am looking exactly----
Dr. Clifford. Mr. Chairman, just to clarify, are you
referring to therapeutic, control, prevention and for feed
efficiency?
The Chairman. Yes.
Dr. Dunham. In that case, based upon the claim that is
coming through, if it is going to be used, we will then review
that indication on the claim and approve that, just as you
said, if it is going to be for therapeutic use, at what dose
and what species. Then at the same time, if you are looking at
this for control or intervention, we do have that. Those are in
the claims.
The Chairman. Mr. Hayes.
Mr. Hayes. No questions.
The Chairman. Mr. Smith.
Mr. Smith. I do have one. I came across this advertisement
in I think CongressDaily, Pew Charitable Trust, ``Bigger Beef,
Tougher Bugs: Antibiotics in Livestock Feed Are Making Our
Drugs Less Effective.'' Dr. Dunham, have you seen this ad?
Would you say that that is an accurate portrayal of the
scenario here?
Dr. Dunham. No, I have not seen the ad, but I just think in
general, all of us, as you have heard discussed today, it is
very important that any of us, be it medicine for humans or
medicines for animals, that we constantly embrace judicious use
of these antimicrobials. The more that you put pressure on
these pathogens, the pressure is just going to have the
potential to enhance resistance. So that is why we do embrace,
all of us, judicious use of these antimicrobials. We want to
make sure that we have access to them. We need them to keep
people and animals healthy. So if we have abuse, we would have
a problem, but people aren't doing that. They are very
conscientious because we do need those. At the same time, just
how many do we have? So you want to treat them very carefully.
So I do believe that, again, the responsible profession is
approaching that in the best manner.
Mr. Smith. Thank you.
Dr. Clifford, would you care to comment on this ad? The Pew
Charitable Trust ran the ad.
Dr. Clifford. I haven't seen the ad. I have read some of
their testimony before, but as far as my position that I have
already stated stands. We need to not present the issues on
fear and concern but on science.
Mr. Smith. Thank you, Mr. Chairman.
The Chairman. Well, thank you both. Do either of you have
any further comment that you would like to make while you are
at the table?
Dr. Dunham. No, sir, I am fine, and I will get you the
answers to the questions that you did ask. Thank you very much
for the opportunity to attend.
The Chairman. Thank you.
Dr. Clifford.
Dr. Clifford. Mr. Chairman, actually I would just like to
make a comment. As Dr. Dunham talked about one world, this goes
back to one world, one health. I think it is critically
important in the scenario of one world, one health that the
human health side and the animal health side work very closely
using science, but remembering that while public health is
important first and foremost to all of us, it is critically
important that we maintain animal health and that animal health
be heard. It is critically important for our livestock
production in this country. Thank you.
The Chairman. Well, thank you for that comment I will just
add to that from my perspective, speaking for myself, I do
believe in the science. I think healthy animals is healthy food
and we have to look to the science of this to assure that,
particularly in this growing, world population, the demand is
going to continue to grow to provide adequate food. It is a big
challenge for us, the science, but that is the way I think we
go. So I appreciate your comments and thank you very much. You
are both excused.
We would like to--as quick as we can--call the second panel
to the table.
I would like to welcome you to the table. Thank you for
being here. I will just recognize each one and then we will
start with Dr. Rowles shortly.
Dr. Craig Rowles, Doctor of Veterinary Medicine, pork
producer, is here on behalf of the National Pork Producers
Council from Carroll, Iowa. Dr. Michael Rybolt, Director,
Scientific and Regulatory Affairs, National Turkey Federation,
Washington, D.C. Dr. Robert Byrne, Ph.D., Senior Vice
President, Scientific and Regulatory Affairs, National Milk
Producers Federation, Arlington, Virginia. Dr. Spangler Klopp,
Doctor of Veterinary Medicine, Diplomat, American College of
Poultry Veterinarians, Corporate Veterinarian, Townsends, Inc.,
on behalf of National Chicken Council, Georgetown, Delaware.
Mr. Blair Van Zetten, President, Oskaloosa Food Products, on
behalf of United Egg Producers from Oskaloosa, Iowa. Dr.
Michael Apley, Doctor of Veterinary Medicine, Ph.D., DACVCP,
Director, PharmCATS Bioanalytical Laboratory, and Associate
Professor, Department of Clinical Sciences, Kansas State
University, on behalf of the National Cattlemen's Beef
Association from Manhattan, Kansas.
Thank you all for being here. We appreciate it. Dr. Rowles,
please begin when you are ready.
STATEMENT OF CRAIG ROWLES, D.V.M., GENERAL MANAGER AND PARTNER,
ELITE PORK PARTNERSHIP, CARROLL, IA; ON BEHALF OF NATIONAL PORK
PRODUCERS COUNCIL
Dr. Rowles. Good morning, Chairman Boswell, Ranking Member
Hayes and Members of the Subcommittee. My name is Craig Rowles.
I am a Doctor of Veterinary Medicine and I have spent 25 years
in the pork industry as a pork producer and a veterinarian. I
have spent the last 12 years as General Manager and Partner of
Elite Pork, and prior to that I was in mixed animal practice in
Carroll serving pork producers.
I am testifying on behalf of the National Pork Producers
Council, an association of 43 state producer organizations that
represent the country's 67,000 pork producers. In providing
pork to the world, producers operate under a set of ethical
principles which broadly include humane and compassionate care
for their pigs. Specific to animal health products, producers
use antibiotics judiciously and responsibly to protect pig
health and to produce safe pork and to manage antibiotic use
and to protect public health. The health and well-being of our
pigs is critical to the success of the U.S. pork industry and
pork producers. Antibiotics are only one tool that help
producers keep their animals healthy, their produce safe,
wholesome and nutritious.
Today, the FDA Center for Veterinary Medicine approves
antibiotics for four uses: disease treatment, disease control,
disease prevention and nutritional efficiency. Pork producers
work in collaboration with their veterinarians to design herd
health programs. These programs may include diagnostics for
determining the best time to vaccinate for diseases or the best
time to use antibiotics for preventing a disease outbreak. The
health management plans may also include information on
ventilation, balanced feed rations or parasite control. These
plans are about total system health management, not just about
what antibiotic to use to treat a specific illness.
U.S. pork producers take the use of antibiotics very
seriously. After 4 years of development and tests, the pork
industry rolled out the first producer responsible antibiotic
use program called Take Care--Use Antibiotics Responsibly. The
program outlines principles and guidelines that protect public
health, animal health and animal well-being through the
responsible use of antibiotics. During the development of Take
Care, the pork industry worked with Federal public health
agencies including CDC and the FDA as well as numerous
stakeholders such as the American Association of Swine
Veterinarians, AVMA, AHI, the American Feed Industry
Association and McDonald's. The pork industry's responsible use
program has been praised by many Federal agencies, legislators,
consumer organizations and food supply companies. The U.S. pork
industry developed this program because it was the right thing
to do. Producers care about animal health and we care about
public health.
Initially a voluntary program, Take Care is now
incorporated into our Pork Quality Assurance Plus program,
which includes on-farm assessments including reviews of whether
antibiotic use principles are being practiced. Producer PQA
Plus certification is required by U.S. packing plants as a
condition of sale.
Denmark's ban on antibiotic growth promoters, or AGPs, for
pigs is often cited as an example of why there should be
restrictions on the use of antibiotics in pork production.
However, the reality of the impacts of that ban are seldom
discussed. After the ban was put in place in 1999 for all
swine, Danish pork producers saw an immediate increase in post-
weaning diarrhea and an increase in nursery pig mortality that
has had long-lasting impacts on the Danish pig industry. In
2002, two Iowa State economists estimated the effect of a ban
on antibiotic use in the U.S. similar to Denmark's would
increase the cost of pork production by $4.50 per pig in the
first year. After 10 years, the ban's cumulative cost to the
pork industry would be greater than $700 million, and that was
back when corn was listed as $2.50. Denmark would not be a wise
course of action for the U.S. pork industry.
Upon graduation from veterinary school, I swore an oath to
use my scientific knowledge and skill for the benefit of
society through the protection of animal health, the relief of
animal suffering, the conservation of animal resources, the
promotion of public health and advancement of medical
knowledge. As a swine veterinarian, I need all the tools
available to live up to that oath. Legislative attempts to ban
certain antibiotics will compromise the oath that every
veterinarian took on his graduation day.
In summary, pork producers and veterinarians have a moral
obligation to use antibiotics responsibly to protect human
health and provide safe food. Producers also have an ethical
obligation to maintain the health of their pigs. Antibiotics
are merely one piece of that healthcare system that pigs need.
The U.S. pork industry has a long history of being proactive
and doing the right thing for its pigs and consumers. Pork
producers developed Take Care and PQA Plus not because they had
to, but because it was the right thing to do.
Thank you for the opportunity to share the views of the
U.S. swine industry, and I would be happy to take your
questions.
[The prepared statement of Dr. Rowles follows:]
Prepared Statement of Craig Rowles, D.V.M., General Manager and
Partner, Elite Pork Partnership, Carroll, IA; on Behalf of National
Pork
Producers Council
Introduction
The National Pork Producers Council is an association of 43 state
pork producer organizations and serves as their voice in Washington,
D.C.
The U.S. pork industry represents a significant value-added
activity in the agriculture economy and the overall U.S. economy.
Nationwide, more than 67,000 pork producers marketed more than 104
million hogs in 2007, and those animals provided total gross receipts
of $15 billion. Overall, an estimated $21 billion of personal income
from sales of more than $97 billion and $34.5 billion of gross national
product are supported by the U.S. hog industry. Iowa State University
economists Dan Otto and John Lawrence estimate that the U.S. pork
industry is directly responsible for the creation of nearly 35,000
full-time equivalent jobs and helps generate 515,000 indirect jobs. All
told, the U.S. pork industry is responsible for more than 550,000
mostly rural jobs in the U.S.
The U.S. pork industry today provides 21 billion pounds of safe,
wholesome and nutritious meat protein to consumers worldwide. In fact,
2007 was the sixth consecutive year of record pork production in the
United States.
Exports of U.S. pork also continue to grow. New technologies have
been adopted and productivity has been increased to maintain the U.S.
pork industry's international competitiveness. As a result, pork
exports have hit new records for the past 16 years. In 2007, exports
represented nearly 15 percent of production. This year, approximately
2.8 billion pounds of pork and pork products are expected to be
exported at a value of $4.1 billion.
In providing pork to the world, producers operate under a set of
ethical principles, which broadly include humane and compassionate care
for their pigs. Specific to animal-health products, producers use
antibiotics judiciously and responsibly to protect pig health, to
produce safe pork and manage antibiotic use to protect public health.
To meet the tremendous demands for pork in the domestic and export
markets, pork producers have designed systems that maximize animal
health and production. Pig barns are built to protect animal health by
providing pigs a controlled climate and protection from the elements
and predators. These barns help ensure that producers can observe
animals daily and that each animal has access to ample water and feed,
which is formulated to provide optimum nutrition for their life stage.
To better manage disease challenges, modern U.S. pork production
uses the practices of multisite production and all-in-all-out pig flow.
Simply stated, that means that after baby pigs are weaned they are
moved to barns that are geographically separated from the breeding
animals. Pork producers strive to keep pigs together in groups that are
the same age and come from the same breeding herd. Pork producers
implement this to minimize disease. Before a new group of pigs is
placed, the barns are completely emptied, cleaned and disinfected.
Antibiotics Used To Protect Pigs, Provide Safe Food
The health and well-being of their pigs is critical to the success
of the U.S. pork industry and pork producers. The prudent use of
antibiotics in the pork industry is essential to providing consumers
safe foods and to ensuring animal health. Antibiotics are only one tool
to help producers do this. Today, the Food and Drug Administration's
(FDA) Center for Veterinary Medicine (CVM) approves antibiotics for
four uses:
1. Disease Treatment: antibiotics used to treat animals after they
are clinically ill.
2. Disease Control: antibiotics used to reduce a specific disease
after the animal has been exposed to the infectious agent.
3. Disease Prevention: antibiotics administered to animals prior to
or directly following exposure to an infectious agent.
4. Nutritional Efficiency: antibiotics used in feed at low
concentrations allow the animals to more efficiently utilize
the feed they eat.
CVM allows antibiotics to be given to pigs through feed or water.
Pigs can also be injected with antibiotics. Producers and veterinarians
work together to make the decisions on how, when and which antibiotics
should be administered.
Pork producers and veterinarians take numerous steps to maximize
animal health and reduce the need to use antibiotics. In addition to
current U.S. pork industry production practices of multisite
production, herd health management programs have been created and
tailored to each production system and often to individual farms.
Pork producers work in collaboration with their veterinarians to
design herd health programs. These programs may include diagnostics for
determining the best time to vaccinate for diseases or the best time to
use antibiotics for preventing a disease outbreak. The health
management plans also may include information on ventilation of the
barns, balanced feed rations and parasite control. The plans are about
total system health management, not just about what antibiotic to treat
a specific illness.
Diagnostics are used when pigs are sick. A producer calls his or
her veterinarian who takes and submits samples to a veterinary
diagnostic laboratory. The results of these tests isolate the bug or
bugs causing the disease, as well as give an indication of the best way
to treat the pigs and prevent the bug from making other groups of pigs
sick.
Pork Industry Developed Guidelines on Antibiotic Use
U.S. pork producers take the use of antibiotics very seriously.
After 4 years of development and tests, the pork industry rolled out
the first producer responsible antibiotic use program, ``Take Care--Use
Antibiotics Responsibly,'' in 2005. The program outlines principles and
guidelines that protect public health, animal health and animal well-
being through the responsible use of antibiotics. During the
development of ``Take Care,'' the pork industry worked with Federal
public health agencies, including the Centers for Disease Control (CDC)
and the FDA, as well as numerous stakeholders such as the American
Association of Swine Veterinarians (AASV), the American Veterinary
Medical Association (AVMA), the Animal Health Institute (AHI), the
American Feed Industry Association (AFIA) and McDonald's. The pork
industry's responsible-use program has been praised by many Federal
agencies, legislators, consumer organizations and food supply
companies. The U.S. pork industry developed this program because it was
the right thing to do. Like all Americans, pork producers care about
animal health and public health.
The guiding principles in ``Take Care'' are:
Take appropriate steps to decrease the need for the
application of antibiotics.
Assess the advantages and disadvantages of all uses of
antibiotics.
Use antibiotics only when they provide measurable benefits.
Complete the Pork Quality Assurance (PQA) Plus Program and
fully implement the management practices prescribed for
responsible use of animal health products into daily
operations.
Use professional veterinary input as the basis for all
medication decision-making.
Antibiotics should be used for treatment only when
there is an appropriate clinical diagnosis.
Limit antibiotic treatment to ill or at-risk animals,
treating the fewest animals indicated.
Antibiotics that are important in treating antibiotic-
resistant infections in human or veterinary medicine should
be used in animals only after careful review and reasonable
justification.
Mixing together injectable or water medications,
including antibiotics, by producers is illegal.
Minimize environmental exposure through proper
handling and disposal of all animal health products,
including antibiotics.
Initially, ``Take Care'' started as a voluntary program, and many
producers participated. Today, however, the pork industry understands
how important it is to use antibiotics responsibly, and ``Take Care''
is the way the U.S. pork industry does business. It's good for our
pigs, it's good for our producers and families, and it's good for the
bottom line. ``Take Care'' has been incorporated into the industry's
Pork Quality Assurance (PQA) Plus program, which includes on-farm
assessments, including reviews of whether the antibiotic-use principles
are being practiced. Producer PQA Plus certification is required by
U.S. packing plants as a condition of sale. Through 4-H and FFA, PQA
Plus, including ``Take Care,'' is also taught to the next generation of
pork producers, as the young producers have an obligation to use
antibiotics responsibly.
The veterinarians working in the U.S. pork industry also have been
proactive in the responsible use of antibiotics. AASV was the first
species-specific veterinary organization to collaborate with FDA and
AVMA to create and endorse judicious-use guidelines for antibiotics.
Addressing Critics' Concerns
There are some who believe that the use of antibiotics in pork
production adversely affects public health. There is ample evidence to
suggest that not only does the responsible use of antibiotics in pork
production protect animal health and welfare, but it may actually
protect public health.
Denmark's ban on antibiotic growth promoters (AGPs) is often cited
as an example of why there should be restrictions on the use of
antibiotics in pork production. However, the reality of the impacts of
the ban on antibiotic growth promoters in Denmark is seldom discussed.
In 1998, Denmark banned the use of AGPs in finishing swine and in all
swine in 1999. It should be noted that this ban was only on the use of
AGPs, not all antibiotics in feed or water. Danish pork producers saw
an immediate increase in post-weaning diarrhea and an increase in baby
pig mortality that has had long lasting impacts on the Danish pig
industry. [1]
These increases in baby pig mortality and the overall impact on
animal welfare might be acceptable if there were improvements to public
health. But public health improvements have not materialized. In fact,
even with intensive surveillance of the public health impacts, the only
demonstrable change to public health could be considered potentially
damaging. The Danes observed an increase in the number of human
Salmonella infections that were resistant to the antibiotic
tetracycline. They believe it was due to an increase in the use of
tetracycline in pigs to combat the post-weaning diarrhea. [2]
Proponents of imposing a similar ban on antibiotic use in the U.S.
cite the drop in total tons of antibiotics used in pork production in
Denmark. While overall use of antibiotics has declined, there has been
a marked increase in the therapeutic use of antibiotics--antibiotics
used for treatment, prevention and control of disease. Today, the use
of therapeutic antibiotics in Danish pigs now surpasses what was used
to promote growth prior to the ban in 1999 and continues to rise each
year. [3] The therapeutic antibiotics used are more modern molecules
considered to be more important in human medicine than the older drugs
used to promote growth. In 2002, two Iowa State economists used an
economic model to estimate the effect that the Denmark ban would have
on U.S. pork production, finding that the cost of production would rise
by $4.50 per pig in the first year after a ban. Over 10 years, a ban's
cumulative cost to the pork industry would be greater than $700
million. (In this model, the economists assumed the price of corn to be
$2.50 per bushel.) Clearly, implementing a ban on antibiotic use
similar to that in Denmark would not be a wise course of action for
U.S. pork producers. [4]
The Danish experience illustrates that if a ban were put in place
in the United States on the use of antibiotics as feed additives, pig
health and well-being would decline. More pigs would suffer, and more
pigs would die.
An Iowa State University study conducted by Dr. Scott Hurd, who now
is USDA Deputy Under Secretary of Food Safety, demonstrated that when
pigs have been sick during their life, those pigs will have a greater
presence of food safety pathogens on carcasses. [5] This study
reinforces the importance of using all of the tools available to
protect the health of animals.
Another study also answers the critics who suggest that raising
animals in large groups inside barns using modern production methods,
including the use of antibiotics, presents a human health threat. Dr.
Wondwossen Gebreyes from the Ohio State University found that pork from
pigs produced in modern, conventional systems had levels of three
foodborne pathogens lower than pigs raised in outdoor systems without
the use of antibiotics. [6]
According to the AVMA, risk assessments on antibiotic use
demonstrate a very low risk to human health from the use of
antimicrobials in food animals, and some models predict an increased
human health burden if antibiotic use in food animals were withheld.
A final word on the issue of AGPs: Contrary to the untruths spread
by some organizations, AGPs represent only 4.6 percent of all
antibiotics given to animals and even the overwhelming majority of
those antibiotics prevents and controls diseases. [7] Additionally,
very few of them are important to human medicine.
Producers Work With Veterinarians
Pork producers work very closely with their veterinarians. Those
swine veterinarians, upon graduation from veterinary school, take an
oath stating that they solemnly swear to uphold their ``scientific
knowledge and skill for the benefit of society through the protection
of animal health, the relief of animal suffering, the conservation of
animal resources, the promotion of public health, and the advancement
of medical knowledge.'' Swine veterinarians need all the tools
available to live up to that oath. Legislative attempts to ban certain
antibiotics will compromise the oath that every veterinarian took on
his or her graduation day.
In summary, pork producers and veterinarians have a moral
obligation to use antibiotics responsibly to protect human health and
provide safe food, both of which are paramount concerns to America's
pork producers. Producers also have an ethical obligation to maintain
the health of their pigs. Antibiotics are merely one piece to the
health care system that pigs need. The U.S. pork industry has a long
history of being proactive and doing the right thing for its pigs and
consumers. Pork producer developed ``Take Care'' and PQA Plus not
because they had to but because it was the right thing to do. The U.S.
pork industry continues to adopt better techniques and new
technologies, but it cannot lose the tools it already has developed,
including antibiotics, to protect the well-being of producers' animals
and the safety of pork.
Notes:
\1\ Agence France-Presse. World-leading pork exporter Denmark sees
sharp increase in pig mortality. Copenhagen Business Online. 2005.
http://archive.wn.com/2005/09/06/1400/copenhagenbusiness/.
\2\ World Health Organization. Impacts of antimicrobial growth
promoter termination in Denmark. Online. 2002. http://
whqlibdoc.who.int/hq/2003/WHO_CDS_CPE_ZFK_2003.1.pdf.
\3\ Danmap 2006. www.Danmap.org.
\4\ Hayes, Jensen, Fabios. Technology choice and the economic
effects of a ban on the use of antimicrobial feed additives in swine
rations. Food Control, 2002.
\5\ Hurd H.S., Brudvig J., Dickson J, et al. 2008. Swine health
impact on carcass contamination and human foodborne risk. Public Health
Reports: (123) pp. 343-351.
\6\ Gebreyes W., Bahnson P., Funk J., et al. 2008. Seroprevalence
of Trichinella, Toxoplasma and Salmonella in antimicrobial-free and
conventional swine production systems. Foodborne Pathogens and Disease:
(5) pp. 199-203.
\7\ Animal Health Institute. 2007. www.AHI.org.
The Chairman. Thank you, Dr. Rowles.
I think we will go right down the table and then we will
come back to questions, so Dr. Rybolt, please.
STATEMENT OF MICHAEL L. RYBOLT, Ph.D., DIRECTOR,
SCIENTIFIC AND REGULATORY AFFAIRS, NATIONAL TURKEY FEDERATION,
WASHINGTON, D.C.
Dr. Rybolt. Good morning, Chairman Boswell, Congressman
Hayes and other Members of the Subcommittee. Thank you for the
opportunity to be here to talk about the advancements in animal
health in the poultry industry. My name is Dr. Michael Rybolt.
I am with the National Turkey Federation. I am the Director of
Scientific and Regulatory Affairs and I also oversee the Turkey
Health and Welfare Committee. NTF, which represents more than
98 percent of the U.S. turkey industry, greatly appreciates the
opportunity to be here to talk about the advances in animal
health within the U.S. turkey industry.
In the United States, turkeys are raised on small family
farms, around 227 acres in size. The advances the turkey
industry has made has allowed these farms to produce large
volumes of safe, wholesome product more efficiently. The
advances have allowed the industry to raise more than 260
million turkeys at an average weight of around 28 pounds. After
processing, this has yielded 6 billion pounds of turkey
products for human consumption. By contrast, in 1970, the
industry only raised 105 million birds with an average live
weight of 17 pounds, which equated to about 1.5 billion pounds
of product for human consumption. The advances the industry has
made in the past 30 plus years have been driven by science and
the dedication of the turkey industry experts with the goal to
produce the safest, highest-quality, nutritious products at an
affordable price for the consuming public. In order to meet
that goal, maintaining the health and welfare of the flock is
paramount. The industry accomplishes this through a variety of
means including raising the birds in environmentally controlled
houses or barns, increased biosecurity on the farms, various
animal health monitoring programs, the use of vaccination
programs and using approved animal drugs or antimicrobials. All
of these tools are important for the industry, and when used
together help the industry meet its goal.
Arguably, one of the most significant advances in the
turkey industry that has played an essential role in improving
the health of the turkey flock is the use of environmentally
controlled houses or barns. Raising birds indoors helps protect
them from predatory wildlife and inclement weather. In turn,
this not only prevents the birds from becoming prey but also
reduces the risk of a flock becoming exposed to disease agents.
Raising turkeys indoors also creates a less stressful
environment for the birds, which research from the University
of Minnesota has shown leads to better production. A well-
treated turkey will grow to its full potential and provide the
consumer with a low-fat, high-protein source.
Likewise, increased biosecurity is also important to
mitigate exposure of the flocks to potential disease-causing
agents. By limiting access to only authorized personnel and/or
ensuring proper sanitation of footwear and clothing, strict
biosecurity is essential to maintain the health and well-being
of our birds. Biosecurity programs have been implemented for
many years and are continually updated and strengthened as
needed, taking into account the latest scientific data.
Additionally, the turkey industry has made significant
advances in the animal disease-monitoring arena. Various
programs exist that have benefited the industry and allowed for
increased production gains. Such programs include the USDA's
National Poultry Improvement Plan, or NPIP. The use of these
programs has allowed the industry to monitor various diseases
and to control and eradicate them before they spread, thereby
allowing for increased livability and more food for humans to
consume.
Unfortunately, like humans, turkeys occasionally will
become ill and will require medication. For some diseases, the
industry has the ability to use prophylactic programs. However,
there are also times when the flocks need to be treated with
antimicrobials for controlling bacterial diseases. The use of
antimicrobials for disease control, prevention and treatment is
necessary for the health and welfare of the turkey flocks.
To raise turkeys without antibiotics would increase the
incidence of illness within the flocks. This would result in a
decrease in density or an increase in the amount of land needed
to raise the additional turkeys to meet the needs of the
consuming public. This would also lead to a decrease in
livability, an estimated ten percent reduction in gain per day,
and a decrease of 0.05 percent in feed conversion.
To compensate for the higher increased illness rates, a
decrease in the feed conversion and to meet the growing need of
the consuming public, we would require 175,550 tons more feed
to feed the turkeys. This increased requirement would equate to
about 3.7 million bushels of corn and 1.7 million bushels of
soybeans just for the turkey industry alone. In order to fill
this need, obviously there would need to be more acreage
planted for crop production or an increase in crop yields.
Obviously there is an economic impact with increased feed
requirements. However, there is also an environmental impact.
The decreased feed conversion leads to less efficiency in
digestion and utilization of the nutrients in that feed and
this will ultimately result in an increase in manure.
With regard to the antibiotic use, each turkey veterinarian
follows a set of prudent use guidelines that were adopted in
1998 by AVMA in conjunction with FDA and CDC for prescribing
and administering antimicrobials to turkey flocks.
Additionally, the flocks that are treated are also required to
undergo a withdrawal period prior to processing to ensure all
antimicrobials have been eliminated from the bird and ensuring
the consumer is not indirectly exposed to the antimicrobials.
USDA's Food Safety and Inspection Service also maintains a
monitoring program that tests for the antibiotic residue levels
in turkey meats to ensure the industry is following the
required withdrawal period. Current data indicates that
virtually all turkeys are free of unsafe residues.
The tools discussed previously have allowed the industry to
make significant improvements in turkey health over the past
decade which has allowed for increased production in a more
efficient manner. Without these tools, the industry would not
be in a position to supply the nearly 6 billion pounds of safe,
wholesome, nutritious turkey products for the consumer. If the
industry were not able to maintain its current status, there
would without a doubt be a decrease in production and an
increase in production costs which would inevitably be passed
onto the consumer.
The increased costs to raise turkeys without antibiotics is
real. One can quickly see the impact on the consumer by walking
into the grocery store and doing a price comparison between two
similar products, one raised conventionally and one raised
without antibiotics. Today at retail outlets here in the D.C.
market, a conventionally raised turkey costs $1.29 per pound. A
similar whole turkey that was produced without antibiotics
costs $2.29 per pound. With the average consumer purchasing a
15 pound whole turkey, that would mean there would be $15
tacked on to their grocery bill. This increased cost to the
consumer is a result of more advanced production practices.
While some consumers are willing and able to afford the
increase, not all Americans have that ability or luxury.
Mr. Chairman and other Members of the Subcommittee, again
let me thank you for the opportunity for the National Turkey
Federation to provide testimony today. The number one goal of
the U.S. turkey industry is to provide safe, wholesome,
nutritious quality turkey products at an affordable cost to the
consumer. All of the advances discussed previously have allowed
the industry to meet its goals. Thank you very much, and I will
be happy to answer any questions.
[The prepared statement of Dr. Rybolt follows:]
Prepared Statement of Michael L. Rybolt, Ph.D., Director, Scientific
and Regulatory Affairs, National Turkey Federation, Washington, D.C.
Good morning Chairman Boswell, Congressman Hayes and Members of the
Subcommittee. Thank you for the opportunity to participate in today's
hearing on the advances of animal health with the livestock and poultry
industry. My name is Dr. Michael Rybolt and I am the Director for
Scientific and Regulatory Affairs for the National Turkey Federation
and staff the Federation's Turkey Health and Welfare Committee. NTF,
which represents more than 98% of the U.S. turkey industry, greatly
appreciates the opportunity to provide comments on the advances in
animal health within the U.S. turkey industry.
In the United States, turkeys are raised on small farms of an
average size around 227 acres. There have been many advances in turkey
production that have allowed the industry to produce a larger volume of
safe, wholesome product more efficiently. These advances allowed the
industry to raise more than 260 million turkeys in 2007, with an
average live weight per bird at 28 pounds. After processing, this
yielded nearly 6 billion pounds of turkey products for human
consumption. By contrast, in 1970, the industry only raised 105 million
birds, with an average live weight of 17 pounds, which provided 1.5
billion pounds of product for human consumption.
The advances the industry has made in the last 30 plus years has
been driven by science and the dedication of turkey industry experts
with the goal to produce the safest, highest quality, nutritious
products at an affordable price. In order to meet that goal,
maintaining the health and well being of the turkey flocks is
paramount. The industry accomplishes this through a variety of means,
including raising the birds in environmentally controlled houses or
barns, increased biosecurity on farms, various animal health monitoring
programs, the use of vaccination programs, and using approved animal
drugs or antimicrobials. All of these tools are important for the
industry and when used together help the industry meet its goal.
Arguably, one of the most significant advances in the turkey
industry that has played an essential role in improving the health of
turkeys flocks is the use of environmentally controlled houses or
barns. Raising birds indoors helps protect them from predatory wildlife
and inclement weather. This in turn not only prevents the birds from
becoming prey but also reduces the risk of the flocks being exposed to
disease agents. Raising turkeys indoors also creates a less stressful
environment for the birds, which research from the University of
Minnesota has demonstrated leads to better production. A well-treated
turkey will grow to its full potential and provide consumers with a
low-fat and high-protein source.
Likewise, increased biosecurity is also important to mitigate
exposure of the flocks to potential disease causing agents. By limiting
access to only authorized personnel and/or ensuring proper sanitation
of footwear and clothing, strict biosecurity is essential to maintain
the health and well being of our birds. Biosecurity programs have been
implemented for many years and are continually updated and strengthened
as needed, taking into account the latest scientific data.
Additionally, the turkey industry has made significant advances in
the animal disease monitoring arena. Various programs exist that have
benefited the industry and allowed for increase production gains. Such
programs include the USDA National Poultry Improvement Plan. The use of
these programs has allowed the industry to monitor for various diseases
and to control and eradicate them before they spread, thereby allowing
for increased livability and more food for human consumption.
Unfortunately, like humans, turkeys occasionally will become ill
and will require medication. For some diseases, the industry has the
ability to use prophylactic programs; however, there are also times
when a flocks needs to be treated with antimicrobials for controlling
bacterial diseases. Use of antimicrobials for disease control,
prevention and treatment is necessary for the health and welfare of the
turkey flocks.
To raise turkeys without antibiotics would increase the incidence
of illness in turkey flocks. This would result in a decrease in density
or an increase in the amount of land needed to raise the additional
turkeys needed to meet the consumer demand. This would also lead to
decreased livability, an anticipated 10% reduction in gain per day and
a decrease of 0.05% in feed conversion.
To compensate for the higher illness rate and resulting decrease in
feed conversion and to meet the growing needs of the consuming public,
an additional 175,500 tons of feed would be required for the turkey
industry. This increase in feed requirement would equate to about 3.7
million bushels of corn and 1.7 million bushels of soybeans, for the
turkey industry alone. In order to fill this need, there would need to
be either more acreage placed into crop production or an increase in
crop yield.
Obviously, there is an economic impact with the increased feed
requirement. However, there is also an environmental impact. The
decrease in feed conversion leads to less efficiency in digestion and
utilization of nutrients, and this ultimately results in an increase in
manure.
With regard to antibiotic use, each turkey veterinarian follows a
set of prudent use guidelines that were adopted in 1998 by the American
Veterinary Medical Association in conjunction with FDA and CDC for
prescribing and administering antimicrobials to the turkey flocks.
Additionally, the turkey flocks that are treated are also required to
undergo a withdrawal period prior to processing to ensure all the
antimicrobial has been eliminated from the birds, ensuring the consumer
is not indirectly exposed to the antimicrobials. The USDA Food Safety
Inspection Service also maintains a monitoring program that test for
antibiotic residues levels in turkey meat to ensure the industry is
following the required withdrawal period. Current USDA data indicates
that 99.9% of samples are free of unsafe residues.
The tools discussed previously have allowed the turkey industry to
make significant improvements in turkey health over the past decades,
which have allowed for the increase in production in a more efficient
manner. Without these tools, the industry would not be in a position to
supply nearly 6 billion pounds of safe, wholesome, nutritious turkey
products for human consumption. If the industry was not able to
maintain its current status, there would without a doubt be decreases
in production and an increase in production cost, which would
inevitably be passed on to the consumer.
The increased costs to raise turkeys without antibiotics are real.
One can quickly see the impact on cost to the consumer by walking into
a grocery store and looking at the price comparison between two similar
products, one that is antibiotic free and the other that is not. Today,
at retail outlets here in the D.C. market, a conventionally raised
whole turkey costs $1.29 per pound. A similar whole turkey that was
produced from antibiotic-free birds costs $2.29 per pound. With the
average consumer purchasing a 15 pound whole bird, that is a $15
increase in the grocery bill. This increase cost to the consumer is a
result of the more advanced production practices. While some consumers
are willing and able to afford the increased cost, not all Americans
have that luxury.
Mr. Chairman and other Members of the Subcommittee, again, let me
thank you for allowing the National Turkey Federation the opportunity
to provide this testimony today. The number one goal of the U.S. turkey
industry is to provide safe, wholesome, nutritious quality products at
an affordable cost to the consumer. All the advances discussed
previously have allowed the industry to meet this goal. Thank you very
much and I will be happy to answer any questions.
The Chairman. Thank you.
Dr. Byrne.
STATEMENT OF ROBERT D. BYRNE, Ph.D., SENIOR VICE
PRESIDENT, SCIENTIFIC AND REGULATORY AFFAIRS,
NATIONAL MILK PRODUCERS FEDERATION, ARLINGTON, VA
Dr. Byrne. Good morning. Thank you, Chairman Boswell,
Ranking Member Hayes and Members of the Subcommittee. My name
is Rob Byrne. I am Senior Vice President of Scientific and
Regulatory Affairs for the National Milk Producers Federation.
The National Milk Producers Federation, based in Arlington,
Virginia, develops and carries out policies that advance the
well-being of dairy producers and cooperatives they own. The
members of NMPF's 31 cooperatives produce the majority of the
U.S. milk supply, making NMPF the voice of more than 40,000
dairy producers on Capitol Hill and with government agencies.
I am very grateful that the Committee is holding this
hearing to review the advances in animal health within the
livestock industry and am pleased to discuss some of these as
they relate to the dairy industry with you. There have been
many advances in animal health in the dairy industry over the
years and these have enabled the industry to become even more
efficient in milk production. As an example of this efficiency,
the dairy industry has changed dramatically in the last 50
years. In 1960, there were 17.6 million dairy cows on 1.8
million dairy farms. In 2008, there were 9.3 million dairy cows
on 59,000 commercial dairy farms in all 50 states. During the
same time, milk production has actually increased from 123
billion pounds per year to almost 190 billion pounds per year.
from these numbers, it is clear that the dairy industry is
producing more milk with many fewer cows on many fewer farms.
At the same time, milk safety and quality have continued to
increase, resulting in the assurance that the dairy industry
provides an abundant supply of high-quality, safe milk for
consumers.
Providing proper care to animals is the best means to
ensure their health and this is of utmost importance to our
members and dairy producers across the country. This is
accomplished on dairy farms through a variety of measures
starting with good herd management. Proper management and
handling of animals keeps them healthy, producing an abundant
supply of high-quality milk. Attention to animal nutrition and
feeding for cows is also important, both to ensure they receive
diets appropriate to their stage in life to keep them healthy
and to ensure that the milk they produce is safe and wholesome.
Last, the veterinary-client-patient relationship is one of the
most important means to make sure that the health of dairy cows
is constantly monitored. A veterinary-client-patient
relationship demonstrates that the dairy farm uses a
veterinarian for health and disease issues, allowing the
producers to use medications appropriately for sick or injured
animals. All of these items are very important in maintaining a
healthy and productive dairy cow.
To address animal care, NMPF is currently completing the
purchase of the Dairy Quality Assurance Center in Stratford,
Iowa, and assuming it within NMPF. The DQA program is widely
recognized throughout the dairy industry as an excellent
educational tool for dairy producers regarding animal care
practices. Through a comprehensive set of best management
practices, the program provides measurable and verifiable
components to allow the industry to prove the good practices
being conducted at the farm. While this program currently
exists as a separate facility, housing it within NMPF will
enable us to create a National Dairy Quality Assurance Program
to assist dairy producers across the country in maintaining a
viable, up-to-date, quality assurance program. This will
provide us an appropriate vehicle to best implement future
advances in animal health within our industry.
Despite all these measures to address animal care and
health, dairy cows occasionally do get sick and sometimes they
must be treated with appropriate medications. When this
happens, there are many safeguards in place to ensure that
residues of these medications do not end up in the milk supply.
I would like to address a few of these areas in a little more
detail to describe how the dairy industry ensures that any
animal health treatments that are given do not have a negative
impact on the quality or safety of milk.
On-farm therapeutic use of animal healthcare products
occurs to cure animals from illness across all stages of their
life. A recent survey of dairy farms in Pennsylvania showed the
therapeutic use of medications on dairy farms for several
illnesses of dairy animals. These illnesses include pneumonia,
metritis, foot rot, enteritis and mastitis. It is important to
note that the majority of animals are actually not treated with
medications, rather, therapeutic usage is reserved for clinical
cases of disease.
The first step in deciding to treat a dairy cow is to use
only medications that are approved by the Food and Drug
Administration's Center for Veterinary Medicine for use in
lactating animals. The process for animal drug approval that we
heard about earlier involves safety assessments and providing
withdrawal times to allow the animal drug to clear the animal's
system. In the case of lactating animals, there are specific
withdrawal times established to ensure that milk is not
contaminated. The milk from any animals that are treated must
be held out of the commercial supply until these withdrawal
times are met. The approval process is very rigorous and
assures that the product is safe both for animals and for the
food supply and consumers.
To reduce the level of potentially harmful bacteria which
result in infections and sickness to animals, dairy cows may
also be treated prophylactically. On-farm prophylactic use of
animal medications occurs in two areas in the dairy industry:
the use of medicated milk replacers fed to calves and the use
of dry cow treatments to prevent mastitis infection during the
dry cow period. Medicated milk replacers are used because
studies have shown an improvement in animal performance and
reduction of scours in dairy calves. Reported usage of
medicated milk replacers on dairy farms ranges from 22 to 70
percent, and the use of medicated milk replacers assists with
the overall health of dairy calves in this important
developmental stage of their life.
Dry cow treatment often involves the use of a long-acting
intramammary infusion given to cows between lactation cycles
with the intention of treating existing infections and
preventing new infections. The use of dry cow treatment is near
universal. For example, in a survey in Washington State, 82
percent of the dairy farms reporting using dry cow treatment on
all of their cows. While dry cow treatment is near universal,
two surveys of antimicrobial resistance of mastitis bacteria in
dairy cattle found no consistent change in the prevalence of
resistance.
Recognizing that lactating dairy cows are occasionally
treated for diseases and to ensure that no animal medications
remain in milk, all milk is screened before it is accepted into
a processing plant. This is a very important control step in
the process, and it is part of a system that the dairy
industry, in cooperation with the states and FDA, established
in the early 1990s.
As part of this regulatory program, a sample from every
tanker of milk that arrives at a processing plant is tested
before milk is unloaded using screening tests that have been
evaluated and approved for use by FDA. Milk that tests positive
is rejected for human consumption and is appropriately
discarded. The dairy farmer causing the positive result must
then pay for the entire load of milk. This costs approximately
$12,000, so there is a large financial incentive to make sure
that no treated dairy cows end up being milked. In addition,
all milk from the dairy farm is then withheld until a negative
farm test is obtained. In 2007, less than .032 percent of all
milk tanker samples tested positive for residues of animal
medications. Milk tanker samples testing positive declined
nearly 70 percent from 1997 to the present, indicating that the
program is effective at detecting and deterring animal
medications in milk.
Proper animal healthcare is the first step in the assurance
that dairy products remain safe and wholesome. In fact, due
largely to the part of the animal healthcare practices, and
milk being the most highly regulated food product in the United
States, dairy foods are lowest among major food groups as the
cause of foodborne illness. Clean conditions, good
manufacturing practices and the adoption of pasteurization have
all enabled dairy products to maintain an excellent safety
record. Of the 2,700 foodborne disease outbreaks summarized by
CDC from 1993 to 1997, only ten were attributed to milk
consumption and seven to cheese consumption. Most foodborne
disease outbreaks associated with milk and cheese are due to
the consumption of raw or unpasteurized milk and raw milk
cheeses that have not been properly aged.
As a result of the entire range of activities at the dairy
farm which start with providing excellent care for animal
health, to the measures taken at the processing plant, the
dairy industry consistently provides a safe, wholesome and
nutritious product for all consumers to enjoy.
Thank you again for the opportunity to appear as part of
this important hearing, and I would be happy to answer any
questions you may have about advances in animal health within
the dairy industry.
[The prepared statement of Dr. Byrne follows:]
Prepared Statement of Robert D. Byrne, Ph.D., Senior Vice President,
Scientific and Regulatory Affairs, National Milk Producers Federation,
Arlington, VA
Thank you Chairman Boswell, Ranking Member Hayes, and Members of
the Committee. My name is Rob Byrne and I am Senior Vice President of
Scientific & Regulatory Affairs for the National Milk Producers
Federation. The National Milk Producers Federation (NMPF), based in
Arlington, VA, develops and carries out policies that advance the well
being of dairy producers and the cooperatives they own. The members of
NMPF's 31 cooperatives produce the majority of the U.S. milk supply,
making NMPF the voice of more than 40,000 dairy producers on Capitol
Hill and with government agencies.
I am grateful that the Committee is holding this hearing to review
the advances of animal health within the livestock industry and am
pleased to discuss some of these as they relate to the dairy industry.
There have been many advances in animal health in the dairy industry
over the years and these have enabled the industry to become even more
efficient in milk production. As an example of this efficiency, the
dairy industry has changed dramatically in the past 50 years. In 1960,
there were 17.6 million dairy cows on 1.8 million dairy farms. In 2008,
there are 9.3 million cows on 59,000 commercial dairy farms in all
fifty states. During this same time, milk production has increased from
123 billion pounds to almost 190 billion pounds. from these numbers, it
is clear that the dairy industry is producing more milk with many fewer
cows on many fewer farms. At the same time, milk safety and quality
have continued to increase, resulting in the assurance that the dairy
industry provides an abundant supply of high quality, safe milk for
consumers.
Providing proper care to animals is the best means to ensure their
health and this is of the utmost importance to our members and dairy
producers across the county. This is accomplished on dairy farms
through a variety of measures, starting with good herd management.
Proper management and handling of animals keeps them healthy and
producing an abundant supply of high quality milk. Attention to animal
nutrition and feeding for cows is also important, both to ensure they
receive diets appropriate to their stage in life, to keep them healthy,
and to ensure that the milk they produce is safe and wholesome. Lastly,
the veterinary-client-patient relationship is one of the most important
means to make sure that the health of dairy cows is constantly
monitored. A veterinary-client-patient relationship demonstrates that
the dairy farm uses a veterinarian for health and disease issues
allowing the producer to use medications appropriately for sick or
injured animals. All of these items are very important in maintaining a
healthy and productive dairy cow.
To address animal care, NMPF is currently completing the purchase
of the Dairy Quality Assurance (DQA) Center in Stratford, Iowa and
assuming it within NMPF. The DQA program is widely recognized
throughout the dairy industry as an excellent educational tool for
dairy producers regarding animal care practices. Through a
comprehensive set of Best Management Practices, the program provides
measurable and verifiable components to allow the industry to prove the
good practices being conducted at the farm. While this program
currently exists as a separate entity, housing it within NMPF will
enable us to create a National Dairy Quality Assurance Program to
assist dairy producers across the country in maintaining a viable, up-
to-date quality assurance program. This will provide us an appropriate
vehicle to best implement future advances in animal health in our
industry.
Despite all of these measures to address animal care and health,
dairy cows occasionally get sick and sometimes must then be treated
with appropriate medications. When this happens, there are many
safeguards in place to ensure that residues of these medications do not
end up in the milk supply. I'd like to address a few areas in more
detail to describe how the dairy industry ensures that any animal
health treatments that are given do not have a negative impact on the
safety or quality of milk.
On-farm therapeutic use of animal health care products occurs to
cure animals from illness across all ages of dairy animals. A recent
survey of dairy farms in Pennsylvania \1\ showed the therapeutic use of
medications on dairy farms for several illnesses of dairy animals.
These illnesses include pneumonia, metritis, foot rot, enteritis, and
mastitis. It is important to note that the majority of animals are
actually not treated with medications; rather therapeutic usage is
reserved for clinical cases of disease.
---------------------------------------------------------------------------
\1\ Sawant, A.A., L.M. Sordillo, and B.M. Jayarao. 2005. A survey
on antibiotic usage in dairy herds in Pennsylvania. J. Dairy Sci.
88:2991-2999.
---------------------------------------------------------------------------
The first step in deciding to treat a dairy cow is to use only
medications that are approved by the Food and Drug Administration's
(FDA) Center for Veterinary Medicine (CVM) for use in lactating
animals. The process for animal drug approval involves safety
assessments and providing withdrawal times to allow the animal drug to
clear the animal's system. In the case of lactating animals, there are
specific withdrawal times established to ensure that milk is not
contaminated. The milk from any animals that are treated must held out
of the commercial supply until these withdrawal times are met. The
approval process is very rigorous and assures that the product is safe
both for animals and the food supply.
To reduce the level of potentially harmful bacteria, which can
result in infections and sickness to animals, dairy cows may also be
treated prophylactically. On-farm prophylactic use of animal
medications occurs in two areas: (1) use of medicated milk replacers
fed to calves and (2) use of dry cow treatments to prevent mastitis
infection during the dry period.
Medicated milk replacers are used because studies have shown an
improvement in animal performance and reduction of scours in dairy
calves.\2\ Reported usage of medicated milk replacers on dairy farms
ranges from 22 to 70%.\3\ \4\ The use of medicated milk replacers
assists with the overall health of dairy calves in this important
developmental stage of their life.
---------------------------------------------------------------------------
\2\ Quigley, J.D., J.J. Drewry, L.M. Murray, and S.J. Ivey. 1997.
Body weight gain, feed efficiency, and fecal scores of dairy calves in
response to galactosyl-lactose or antibiotics in milk replacers. J.
Dairy Sci. 80:1751-1754.
\3\ Raymond, M.J., R.D. Wohrle, and D.R. Call. 2006. Assessment and
promotion of judicious antibiotic use on dairy farms in Washington
State. J. Dairy Sci. 89:3228-3240.
\4\ Sawant, A.A., L.M. Sordillo, and B.M. Jayarao. 2005. A survey
on antibiotic usage in dairy herds in Pennsylvania. J. Dairy Sci.
88:2991-2999.
---------------------------------------------------------------------------
Dry cow treatment often involves the use of ``a long-acting
intramammary infusion given to cows between lactation cycles with the
intention of treating existing infections and preventing new
infections.'' \5\ The use of dry cow treatment is near universal. For
example in a survey from Washington State, 82% of dairy farms reported
using dry cow treatment on all of their cows.\6\ While dry cow
treatment is near universal, two surveys of antimicrobial resistance of
mastitis bacteria in dairy cattle found no consistent change in the
prevalence of resistance.\7\ \8\
---------------------------------------------------------------------------
\5\ Ibid.
\6\ Ibid.
\7\ Erskine, R.J., R.D. Walker, C.A. Bolin, P.C. Bartlett, and D.G.
White. 2002. Trends in antibacterial susceptibility of mastitis
pathogens during a seven-year period. J. Dairy Sci. 85:1111-1118.
\8\ Makovec, J.A., and P.L. Ruegg. 2003. Antimicrobial resistance
of bacteria isolated from dairy cow milk samples submitted for
bacterial culture: 8,905 samples (1994-2001). J. Am. Vet. Med. Assoc.
222:1582-1589.
---------------------------------------------------------------------------
Recognizing that lactating dairy cows are occasionally treated for
diseases and to ensure that no animal medications remain in milk, all
milk is screened before it is accepted into a processing plant. This is
a very important control step in the process and is part of a system
that the dairy industry, in cooperation with the states and FDA,
established in the early 1990's. As part of this regulatory program, a
sample from every tanker of milk that arrives at a processing plant is
tested before milk is unloaded using screening tests that have been
evaluated and approved for use by FDA. Milk that tests positive is
rejected for human consumption and appropriately discarded. The dairy
farmer causing the positive result must then pay for the entire load of
milk. This costs approximately $12,000, so there is a large financial
incentive to make sure that no treated dairy cows are milked. In
addition, all milk from the dairy farm is then withheld until a
negative farm test result is obtained. In 2007 less than 0.032% of all
milk tanker samples tested positive for residues of animal
medications.\9\ Milk tanker samples testing positive declined by nearly
70% from 1996-2005 indicating that the program is effective at
detecting and deterring animal medications in milk.\10\ \11\
---------------------------------------------------------------------------
\9\ National Milk Drug Residue Database: Fiscal Year 2007 Annual
Report. Available online at: http://www.cfsan.fda.gov/8acrobat/
milkrp07.pdf.
\10\ Ibid.
\11\ National Milk Drug Residue Database: Fiscal Year 1996 Annual
Report. Available online at: http://www.cfsan.fda.gov/8ear/
milkrp96.html
---------------------------------------------------------------------------
Proper animal health care is the first step in the assurance that
dairy products remain safe and wholesome. In fact, due largely in part
to these animal health care practices, and milk being the most highly
regulated food product in the United States,\12\ dairy foods are lowest
among major food groups in the cause of foodborne illness. Clean
conditions, good manufacturing practices, and the adoption of
pasteurization have all enabled dairy products to maintain an excellent
safety record. Of 2,751 foodborne disease outbreaks summarized by the
Center for Disease Control (CDC) from 1993-1997, ten were attributed to
milk consumption (0.36%) and seven to cheese consumption (0.25%).\13\
Most foodborne disease outbreaks associated with milk or cheese
consumption is due to the consumption of raw (unpasteurized) milk or
raw milk cheeses that have not been properly aged.
---------------------------------------------------------------------------
\12\ Milk production is regulated under the Grade ``A'' Pasteurized
Milk Ordinance.
\13\ S.J. Olsen, L.C. MacKinnon, J.S. Goulding, N.H. Bean, L.
Slutsker. 2000. Surveillance for foodborne-disease outbreaks--United
States, 1993-1997. MMWR CDC Surveill. Summ. Mar. 17;49(1):1-62 (Most
recent summary).
---------------------------------------------------------------------------
As a result of the entire range of activities at the dairy farm,
which start with providing excellent care for animal health, to the
measures taken at the processing plant, the dairy industry consistently
provides a safe, wholesome, and nutritious range of products for all
consumers to enjoy.
Thank you again for the opportunity to appear as part of this
important hearing. I will be happy to answer any questions you may have
about advances in animal health within the dairy industry.
The Chairman. Thank you.
Dr. Klopp.
STATEMENT OF SPANGLER KLOPP, D.V.M., D.A.C.P.V.;
CORPORATE VETERINARIAN, TOWNSENDS, INC.,
GEORGETOWN, DE; ON BEHALF OF NATIONAL CHICKEN COUNCIL
Dr. Klopp. Good morning, Chairman Boswell, Congressman
Hayes. I thank you for the opportunity to be here to speak on
behalf of the National Chicken Council. My name is Buzz Klopp.
I am a practicing poultry veterinarian and have been so for 36
years.
For the past 14 years, I have worked for Townsends
Incorporated, which is an integrated broiler chicken growing
and processing company. We grow and process chickens in the
States of North Carolina and Arkansas. The chicken industry
itself has made exceptional advances over the decades and this
is due in large part to the lead of science and just a lot of
hard work and a lot of smart thinking by a lot of different
people. Today's industry grows approximately nine billion
chickens a year. We grow these chickens on approximately 34,000
independently owned and operated farms. Now, chickens are like
anything else. They are a business, and the health of chickens
is very important to the business, and maintaining the health
of chickens is predicated on prevention of disease. We do this
principally through vaccination, appropriate use of antibiotics
and other antimicrobials, and good old sound poultry husbandry,
or chicken house management, as we call it.
We have some basic parameters that we use for measuring
health and performance of chickens. One of these is average
daily gain. This is nothing more than how fast does the chicken
grow, how much does it grow every day. Another basic parameter
that we use is livability: of the number of chicks we place on
a farm, how many of them do we take to the processing plant to
process for food. The third parameter we use is condemnation at
processing. The USDA has a presence in every one of our plants
and they reject and discard carcasses that are unfit for human
consumption. These are referred to as condemned carcasses,
percentage condemnation rates.
We use vaccines to control diseases that cannot be
controlled by antibiotics and husbandry. Antibiotics are used
for control of specific types of bacterial and parasitic
diseases. Now, I want to go back to the three parameters that
we use in measuring chicken health and performance: average
daily gain, or ADG, is the acronym. Back in the early 1970s
when I came in the industry, we talked about a 4 pound chicken
at 8 weeks of age. Today we talk about a 5\1/2\ pound chicken
at 50 days of age. If we had to go back to the previous rates
of average daily gain, we would need approximately
2,484,000,000 more chickens to be grown and processed in this
country.
If we look at livability, livability percentages in the
early 1980s were approximately 93\1/2\ percent. For today, the
approximate livability is 95.6 percent. This is a real
improvement of approximately 2.1 percent. Again, based on the
nine billion chickens, if we do not have the appropriate
interventions, we would have to have another 190,800,000 day
old chicks placed to meet today's needs of the American public.
If we look at condemnation at processing and the
improvement here, I have actually put a percentage to this, it
is 456 percent over 42 years, and I have broken it down in a
chart that is on the page. I am not going to bore you with all
of the details of what those are. If you want to know, I will
be happy to answer your questions. But again, without the
interventions that we have available to us today, we would have
to place and produce another 155,700,000 chickens to meet the
needs of the American public.
Collectively, without the usage of the appropriate
interventions that we have, this would total up to the need to
raise approximately 2,830,500,000 more chickens to meet today's
need. I think we all know that the population of the world is
not holding on a steady line, it is not declining, it is
increasing. So it is more food we need, not less food.
It is important to remember when we talk about chickens and
a lot of other animals that these are free-roaming animals, and
chickens are like dogs, cows, pigs, a lot of animals. They pick
at the ground. That is just their nature. So they are very
prone for the development of diseases of the gastrointestinal
tract, and the occurrence of antibiotic resistance is not due
to us in the chicken industry. We have been concerned about it.
Like I said, I have been a practicing veterinarian for 36
years. We have been concerned with antibiotic resistance from
that very time, and we manage this through the proper and sound
usage of the products available to us through rotation
programs, through dosage selections, through the proper
selection of the given intervention available to us.
Good chicken health is maintained through the responsible
use of vaccines and antibiotics, and this is important not just
to me, not just to my industry, but it is important to the
American public. The adage that I use a lot of times is, hungry
people are not happy people, and if you want to see a person
that fits that mold, be around me if I don't each lunch. My
whole personality changes.
Now, in today's day, we end up producing a lot of different
types of chickens, and we do produce some antibiotic-free
chickens, and we have found, shock, shock, exactly what we
would expect. We had 2.91 percent lower livability. We had
basically 33 points lower average daily gain and over a quarter
percent higher condemnation at processing. What this results in
is not only less food but it results in food at a higher cost
to the American consumer. The other thing that should be
addressed here, and some of my colleagues have mentioned is,
there are environmental impacts to growing more animals, and if
we are going to do this, we are going to have a whole side
range of aspects that are going to have to be evaluated.
So in conclusion, I say to you, and I really do appreciate
the opportunity to be here, that antibiotics are important to
the industry as far as disease control is concerned and the
phrase of today is ``animal welfare.'' In my years, we always
talked about chicken house management or poultry husbandry or
animal husbandry but today it is animal welfare, and the use of
antibiotics is very important in that aspect as well as to the
sustainability of American agriculture. I want to go back to
the fact that we grow our chickens on approximately 34,000
independently owned and operated farms, and the other part that
is important, and I think that is why we are here, is that the
appropriate use of antibiotics and interventions, it is
important to the American public, yes, in terms of antibiotic
resistance and sensitivity, but also in terms of producing a
good, sound, nutritious, economically affordable food product.
I thank you very much for the opportunity to be here, and I
will be happy to entertain any questions.
[The prepared statement of Dr. Klopp follows:]
Prepared Statement of Spangler Klopp, D.V.M., D.A.C.P.V.; Corporate
Veterinarian, Townsends, Inc., Georgetown, DE; on Behalf of National
Chicken Council
Good morning Chairman Boswell, Congressman Hayes, and Members of
the Subcommittee. Thank you, Chairman Boswell for the opportunity to
participate in this important hearing on the advances of animal health
with the livestock industry. On behalf of the National Chicken Council,
I appreciate your invitation to provide comments on the advances in
chicken health in the U.S. chicken industry.
My name is Spangler Klopp and I am the Corporate Veterinarian at
Townsends, Inc. and former Chairman of the National Chicken Council
Poultry Health Committee.
The raising of chickens to produce food for human consumption has
made exceptional advances over the decades due in large part to
ingenuity and intelligence in following the lead of the sciences and a
great deal of hard work. Today's broiler chicken industry processes
approximately nine billion chickens/year, representing over $37 billion
dollars in value. These chickens are raised to an average live weight
of 5.53 lbs with a 75% yield at processing resulting in approximately
37.5 billion pounds of chicken meat, valued at over $37 billion, for
human consumption. The broiler industry contributes to sustainable
agriculture by raising its chickens on approximately 34,000
independently owned and operated farms.
Maintaining the health of chicken flocks is predicated on disease
prevention through vaccination, appropriate use of antibiotics and
other antimicrobials and sound poultry husbandry. Critical measurement
parameters for chicken performance are rate of gain, (Average Daily
Gain or ADG), percentage livability, (number of chicks placed divided
by number moved to processing), percentage condemnation at processing,
(number of carcasses deemed unfit by USDA for human consumption divided
by the number of chickens processed).
Vaccines control diseases that cannot be controlled by antibiotics
and husbandry. Antibiotics are used for control of specific bacterial
and parasitic diseases especially those of the gastrointestinal tract.
Such usages allow for improved health as indicated by improved
livability, average daily gain and carcass condemnation at processing.
ADG in the early 1970's was defined as 4 pound live weight at 56
days of age or .0714 pound ADG. Today, the approximate figure for ADG
is .1139 based on an average processing weight of 5.53 pounds. This
represents a 160% increase in efficiency and that much more meat per
chicken. Without today's technologies, approximately 2,484,000,000 more
chickens would be required annually to meet the food demands of the
American public.
Percentage livability was approximately 93.52 in the early 1980s
and the figure for today is approximately 95.64. This represents a real
improvement of 2.12% and that much more meat per flock. Based on the
national figure of nine billion chickens processed, without this
improvement in livability, an additional 190,800,000 day old chicks
would have to be placed annually to meet the needs of the American
public.
Condemnation percentage improvement, shown below, in the past 42
years is 456% and represents improved meat quality, from taste,
nutritional and microbiological aspects. If condemnations were at the
level of earlier years, another 155,700,000 chickens would have to be
grown annually to meet the needs of the American Public. Collectively,
if the industry was not allowed use of appropriate interventions, an
additional 2,830,500,000 chickens would have to be grown and processed
annually to meet the needs of the American public.
Percentage Field Related USDA Carcass Condemnation of Broiler Chickens
for Two Selected Years
------------------------------------------------------------------------
Category 1965 * 2007 **
------------------------------------------------------------------------
Leukosis .512 .028
Septicemia/Toxemia .563 .238
Airsacculitis .922 .109
Inflammatory process .128 .113
(IP)
Synovitis .102 .0003
------------------------------------------------
Total Field.......... 2.227 0.4883
------------------------------------------------------------------------
* Dr. L.V. Sanders, USDA, National meeting on Poultry Condemnations,
Salisbury, MD, October 18-19, 1966.
** NASS/USDA/Slaughter Report, January-December, 2007, converted to
percentages.
It is important to remember that broiler chickens are free roaming
and have certain natural tendencies, which include ``picking at the
ground or litter.'' Thus disease control becomes a function of
maintaining a balance between the chicken and its environment. Vaccines
and antibiotics have played significant roles in the improvement of the
health parameters cited above and are valued accordingly. Their usage
is rigidly monitored by educated and trained professionals.
The development of antibiotic resistant bacteria has been a concern
of the industry long before the subject became popular with others and
is viewed even more importantly today. Sound usage/rotational programs,
proper pharmaceutical selection for use and use of proper dosage
regimes have allowed for the continued effectiveness of antibiotics,
some of which have been in use for over 25 years. Maintenance of
antibiotic sensitivity at the chicken house level is an important
issue.
Good chicken health through the responsible use of vaccines and
antibiotics is obviously important in feeding the American Public and
is equally important in enhancing the quality of the environment and
socioeconomic style of life in rural America. Healthy chickens require
less feed while using less housing space, produce less manure and
produce more meat as compared to the option of not having these
important interventions for our use.
In my current experience of producing chickens raised without
antibiotics, those flocks have a 2.91% lower livability, 0.0033 lower
ADG and a 0.275% higher condemnation. This may be fine for niche
markets that cater to consumers who can afford to pay higher prices for
chicken. But as I previously noted, without the use of appropriate
interventions, an additional 2,830,500,000 chickens would have to be
grown each year to meet the needs of the American public. Additionally,
this loss would result not only in less food but also at a higher cost
with more potential issues to the environment and to the way of life in
rural America.
In conclusion, it is apparent that antibiotics are important in
disease control or as described in today's vernacular--animal welfare--
as well as to the sustainability of American Agriculture and to the
American public in general.
The Chairman. As long as it doesn't get into lunchtime.
Thank you.
Mr. Van Zetten.
STATEMENT OF BLAIR VAN ZETTEN, PRESIDENT, OSKALOOSA FOOD
PRODUCTS CORP., OSKALOOSA, IA; ON BEHALF OF UNITED EGG
PRODUCERS
Mr. Van Zetten. Mr. Chairman, Mr. Vice Chairman, thank you
for the opportunity to testify. My name is Blair Van Zetten. I
am a proud member of the Iowa egg industry. We are the nation's
number one egg-producing state. My company, Oskaloosa Food
Products, produces liquid, frozen and dried egg products for
the food industry.
I am a member of the United Egg Producers. I am also a
member of the Further Processors Division of United Egg
Association. Animal healthcare is a critical concern for both
of these organizations. UEP and UEA's Further Processor
Divisions have taken a leadership role in animal health, and
here are just a few examples.
We supported the development of USDA'S Low Pathogenic Avian
Influenza Program, a voluntary effort through the National
Poultry Improvement Plan to prevent, control and identify LPAI
throughout the poultry industry. We participated in the
original design of the program and the private sector
participants in NPIP, and worked with the Department of
Agriculture and Congress to develop regulations for the program
to secure adequate funding. Fortunately, the highly pathogenic
H5N1 strain of avian influenza has never been found in North
America. However, we all know that we have a responsibility to
guard against this threat to both animal and human health. We
have worked with respected academic and veterinarian experts to
develop procedures for safe movement of eggs and egg products
into and out of the quarantine zones in the event of an
outbreak of highly pathogenic avian influenza.
We presented our findings and recommendations to USDA
veterinary experts and worked closely with them to ensure the
maximum protection of both human and animal health. Just this
week, UEP in conjunction with USDA and other animal health
officials hosted a national conference to advance the egg
industry's program that will ensure the containment of highly
pathogenic avian influenza, should it be found, as well as the
continuity of the nation's egg supply.
We have worked to encourage all egg producers to register
their premises under USDA's voluntary National Animal
Identification System. If there is a disease outbreak, it is
critical for USDA and the public health authorities to be able
to locate and contact all producers in the affected area as
soon as possible. The NAIS will make this easier.
Nearly all egg producers have implemented quality assurance
programs on their farms. These QA programs are primarily aimed
at preventing Salmonella enteritidis, but they also provide
important benefits for animal health, and because of the way
they are designed, in particular, producers enforce strict
biosecurity programs and take other steps that not only help
bird health but have human health benefits as well.
As part of our quality assurance and animal health
programs, we routinely vaccinate for various infectious
diseases of foodborne pathogens. Early in a bird's life, often
on the first day of age, we administer vaccines for respiratory
and immunosuppressive diseases. Some producers also vaccinate
for Salmonella enteritidis. These vaccines may be live,
inactivated or a combination, depending on the disease and the
producer's own management practices.
Nowadays we often get questions about antibiotics.
Antibiotics aren't considered a food safety issue for eggs. Low
levels of antibiotics are occasionally used to prevent or treat
disease and ensure the health of the laying hens, just as for
humans. Few antibiotics are permitted in commercial layers by
regulations, and there is an economic incentive not to use them
due to the additional cost. Because so few antibiotics are used
and are used to such a small degree, they aren't likely to
contribute to the problem of antibiotic resistance.
In our own operations, we use antibiotics only for
treatment. In my written statement, I have listed examples of
several antibiotics that might be used in our industry and the
disease which they treat. Through careful and appropriate
regulations, the animal agriculture industry's ability to use
antibiotics when necessary can and should be preserved. As a
relatively small industry, we are a less lucrative market for
veterinary drug makers than other larger segments of animal
agriculture. Therefore, we are sensitive to whether the drug
makers have incentives to develop new products.
It is important to us that the regulation of antibiotics be
based on sound science, not emotions, politics or popular
press. We think science is the best basis on which to make
highly technical public policy decisions. It is critical that
regulators have the resources to do their jobs efficiently and
thoroughly, and we hope Congress will continue to address FDA
resource needs.
Beyond the availability of veterinary products, it is also
important that Congress find more resources for research in
animal health issues. The work that our scientists do provides
many benefits to the public and to our industry. Unfortunately,
the funding for animal agricultural research has been stagnant
for many years. There are many reasons to increase this
research but one of them is surely to advance animal health.
That will improve the welfare of animals under our care and
also benefit consumers.
Mr. Chairman, I thank the Subcommittee for its oversight in
these matters, and I will be happy to try and answer any
questions you may have.
[The prepared statement of Mr. Van Zetten follows:]
Prepared Statement of Blair Van Zetten, President, Oskaloosa Food
Products Corp., Oskaloosa, IA; on Behalf of United Egg Producers
Mr. Chairman and Members of the Subcommittee, thank you very much
for the opportunity to testify today. My name is Blair Van Zetten and I
am a proud member of Iowa's egg industry. We are the nation's number-
one egg-producing state. My company, Oskaloosa Foods, produces liquid,
frozen and dried egg products for the food industry.
About \1/3\ of all the eggs produced in the United States are
destined for further processing. In many cases, these eggs will become
ingredients in a broad range of foods, bringing high-quality protein
and other nutritional advantages as well as a number of functional
properties that make the foods better and more convenient.
I am a member of United Egg Producers (UEP), as are the producers
of about 98% of the nation's eggs. I am also a member of the Further
Processors Division of United Egg Association (UEA). Animal health is a
critical concern for both of these organizations.
Our industry pays a great deal of attention to animal health for
several reasons.
As producers, we care about the welfare of the birds under
our care.
Healthier birds are more productive and animal health is
directly related to our ability to stay in business as
producers.
Good animal health leads to a better, safer, more affordable
product for our ultimate customer, the consumer.
I am proud to say that UEP and UEA's Further Processor Division
have taken a leadership role in animal health. Here are just a few
examples of what we and our industry have been doing in recent years:
We supported the development of USDA's Low-Pathogenic Avian
Influenza Program--a voluntary effort through the National
Poultry Improvement Plan to prevent, control and indemnify LPAI
throughout the poultry industry. We participated in the
original design of this program as private-sector participants
in NPIP, and worked with the Department of Agriculture and
Congress to develop regulations for the program and secure
adequate funding. Virtually all of our membership participates
in this program.
Fortunately, the highly pathogenic Asian H5N1 strain of
avian influenza has never been found in North America, not even
among wild birds, much less domesticated poultry. However, we
all know that we have a responsibility to guard against this
threat to both animal and human health. We have worked with
respected academic and veterinary experts to develop procedures
for the safe movement of eggs and egg products into and out of
quarantine zones in the event of an outbreak of highly
pathogenic avian influenza. We've presented our findings and
recommendations to USDA veterinary experts and worked closely
with them to ensure the maximum protection for both human and
animal health. Just this week UEP, in conjunction with USDA and
other animal health officials, hosted a national conference to
advance an egg industry program that will assure the
containment of highly pathogenic avian influenza should it be
found anywhere in the United States and the continuity of the
nation's egg supply in such an event.
We have worked to encourage all egg producers to register
their premises under USDA's voluntary National Animal
Identification System. If there is a disease outbreak, it is
critical for USDA and public health authorities to be able to
locate and contact all producers in the affected area as soon
as possible. The NAIS will make this easier, and minimize the
time during which producers' ability to market their products
is restricted.
Nearly all egg producers have implemented quality assurance
programs on their farms, either through state programs or as
part of programs designed by their own companies or their
customers. These quality assurance programs are primarily aimed
at preventing Salmonella enteritidis, but they also provide
important benefits for animal health because of the way they
are designed. In particular, producers enforce strict
biosecurity programs, control for disease vectors like rodents,
and take other steps that not only help bird health but have
human health benefits as well.
As part of our quality assurance and animal health programs,
we routinely vaccinate for various infectious diseases or
foodborne pathogens. Early in a bird's life--often on the first
day of age--we administer vaccines for respiratory diseases
such as Newcastle disease and infectious bronchitis; and
immunosuppressive diseases such as Marek's disease and
infectious bursal disease. Some producers also vaccinate for
Salmonella enteritidis. These vaccines may be live, inactivated
or a combination, depending on the disease and the producer's
own management practices. We encourage support for USDA's
biologics division, which has been understaffed, to improve the
development and timeliness of vaccine availability.
Nowadays, we often get questions about antibiotics. Antibiotics
aren't considered a food safety issue for eggs. Low levels of
antibiotics are occasionally used to prevent or treat disease and
ensure the health of laying hens, just as for humans. Very few
antibiotics are permitted in commercial layers by regulations, and
there is an economic incentive not to use them due to the additional
cost. Because so few antibiotics are used, and are used to such a small
degree, they aren't likely to contribute to the problem of antibiotic
resistance.
In our own operations, we use antibiotics only to treat diseases.
Examples of some antibiotics that might be used in our industry would
be tylosin to treat mycoplasma infections, chlortetracycline to treat
E. coli respiratory infections, and bacitracin to treat necrotic
enteritis and other enteric diseases.
Through careful and appropriate regulation, the animal agriculture
industry's ability to use antibiotics when necessary can and should be
preserved. As a relatively small industry, we are a less lucrative
market for veterinary drug makers than other, larger segments of animal
agriculture. Therefore, we are sensitive to whether the drug makers
have incentives to develop new products.
It is important to us that the regulation of antibiotics be based
on sound science, not emotions, politics or the popular press. We think
science is the best basis on which to make highly technical public
policy decisions. It is critical that regulators, in this case the Food
and Drug Administration, have adequate resources to do their jobs
efficiently and thoroughly, and we hope Congress will continue to
address FDA's resource needs.
Beyond the availability of veterinary products, it is also
important that Congress find more resources for research in animal
health issues. The work that our scientists do provides many benefits
to the public and to our industry. As just one example, USDA's
Agricultural Research Service demonstrated conclusively that the low-
pathogenic avian influenza virus is inactivated through pasteurization,
a process that all processed egg products undergo. Not only did this
work give important reassurance to consumers, and inform industry
practice, but it has also been enormously helpful to us in
communicating to our overseas trading partners the safety of our
products. Unfortunately, the funding for agricultural research has been
stagnant for many years. There are many reasons to increase this
research, but one of them is surely to advance animal health: That will
improve the welfare of the animals under our care, and also benefit
consumers.
Mr. Chairman, I thank the Subcommittee for its oversight in these
matters, and will be happy to try and answer any questions you may
have.
The Chairman. Thank you.
Dr. Apley.
STATEMENT OF MICHAEL D. APLEY, D.V.M., Ph.D., D.A.C.V.C.P.,
ASSOCIATE PROFESSOR OF BEEF PRODUCTION MEDICINE, CLINICAL
PHARMACOLOGIST, AND DIRECTOR, PharmCATS BIOANALYTICAL
LABORATORY, KANSAS STATE UNIVERSITY; MEMBER, CATTLE HEALTH AND
WELL BEING COMMITTEE, NATIONAL CATTLEMEN'S BEEF ASSOCIATION,
MANHATTAN, KS
Dr. Apley. Mr. Chairman, Ranking Member Hayes, other
Members of the Subcommittee, my name is Mike Apley and I am an
Associate Professor of Beef Production Medicine and a Clinical
Pharmacologist at Kansas State University.
I think one of the most important pieces of information
that should come out of today's hearing is consumers need to
know that by law, no meat sold in the United States is allowed
to contain drug residues that violate FDA standards and
additionally, all products approved by the FDA for use in food-
producing animals must first pass significant human food safety
benchmarks.
Animal drugs are important in treating disease, but more
important is prevention, utilizing cattle management and
vaccines. An example is the increasing availability of
backgrounded cattle which have been immunized for bovine
respiratory disease and held in local environments to overcome
the stress of weaning prior to being shipped to a feeding
facility. Another example of management practice is reducing
the need for therapeutic intervention. It is a system which
involves periodically moving cows which have not yet calved
away to new calving areas and leaving behind the cows which
recently calved. In this way, any shedding of disease organisms
and related disease outbreaks are isolated within a subset of
the animals and is prevented from spreading to the entire herd.
However, when we can't prevent disease, we do need animal
drugs to control it. An example is the use of an antimicrobial
in controlling anaplasmosis in cattle. You may be familiar with
this disease. It is a bloodborne parasite for which we do not
have an adequate vaccine. In older cattle, this disease is
often fatal. Chlortetracycline may be fed to cattle at risk for
the disease during and immediately after the vector season to
control clinical signs.
This disease is a good example for examining the use of the
term ``subtherapeutic,'' which is often interpreted to mean low
dosage. In the case of anaplasmosis, a relatively low dose of
the antimicrobial is effective in controlling a disease that
can result in suffering and death of the cattle as well as
economic devastation to the producer. The subtherapeutic
categorization attempts to cast all antimicrobial regimens
below an undefined threshold as inappropriate due to potential
selection for resistant pathogens. In reality, resistant
organism selection pressure is much, much more complicated than
just a high concentration for a short term is good or a lower
concentration for a longer exposure is bad. The use of the term
``subtherapeutic'' to me indicates a cursory knowledge of the
effects of antimicrobials in food animals relating to animal
well-being, disease control and food safety. Each application
of an antimicrobial is different and the attempts to supersede
the regulatory process with blanket legislation prohibiting
subtherapeutic uses will result in instances where a decreased
ability to address disease pressures in cattle production will
not be offset by a benefit in antimicrobial resistant
selection. Circumventing the approval process and making leaps
from effect back to cause will undermine the ability of the
cattle industry to address disease challenges and in many cases
may result in no benefit to human therapeutics.
As Congress continues to have an interest in this issue, we
recommend that the focus be put on the tools already in place
rather than imposing new rules, regulations and prohibitions on
animal agriculture. One way to do this would be to ensure that
the National Antimicrobial Resistance Monitoring System, or
NARMS, and the Food Animal Residue Avoidance Databank, or
FARAD, be fully supported and funded. NARMS was developed to
monitor changes in susceptibility of select bacteria to
antimicrobial agents of human and veterinary importance. FARAD
is another valuable tool that Congress and the Administration
neglected. FARAD is a computer-based system that is invaluable
in helping to avoid drug residue problems and keeping the food
supply safe. Unfortunately, the funding for FARAD runs out next
week, and unless Congress adds funding to the CR, the valuable
information it holds will be gone.
Finally, I would like to talk about the steps the industry
has taken to police themselves. The Beef Quality Assurance, or
BQA program, has set forth recommendations for how cattle
producers should use antibiotics to protect and maintain the
health of their animals. BQA was established in 1987 to provide
cattle producers with the principles and tools to use every day
to ensure animals are given proper care and attention.
In conclusion, we find that in today's cattle industry, the
need for animal health interventions that focus on prevention
of disease, control of disease pressure and therapy of animals
with disease is critical to the success of cattle producers
across the country, as well as helping to keep our food supply
safe. Antimicrobial drugs are a very important part of our
carefully selected tools and should not be removed from use
without definitive proof of a benefit to human health that
overrides the increased suffering and economic losses that
would be experienced in the cattle industry.
Thank you for the opportunity to testify.
[The prepared statement of Dr. Apley follows:]
Prepared Statement of Michael D. Apley, D.V.M., Ph.D., D.A.C.V.C.P.,
Associate Professor of Beef Production Medicine, Clinical
Pharmacologist, and Director, PharmCATS Bioanalytical Laboratory,
Kansas State University; Member, Cattle Health and Well Being
Committee, National Cattlemen's Beef Association, Manhattan, KS
Chairman Boswell, Ranking Member Hayes, and Members of the
Committee, my name is Mike Apley. I am an Associate Professor of Beef
Production Medicine, a Clinical Pharmacologist, and the Director of the
PharmCATS Bioanalytical Laboratory located at Kansas State University.
I am also a Member of the National Cattlemen's Beef Association's
(NCBA) Cattle Health and Well Being Committee. I appreciate the
opportunity to be here today to talk about the use of drugs to prevent
and treat disease within the cattle industry.
Animal health and well-being are top priorities for cattle
producers across the country. Without healthy animals, we do not have a
healthy industry, so we utilize important tools like vaccines,
antimicrobials, and other drugs to control disease, treat disease, and
provide a higher quality of life for our cattle while keeping the food
supply safe. Ongoing activist and media reports, however, suggest that
the use of drugs in animal agriculture is often inappropriate and that
the use of drugs is poorly controlled. Misleading statements such as
these have put an undue spotlight on animal drugs and threatens to
undermine the science-based approval process we have for these
products. One of the most important pieces of information that should
come out of today's hearing is that consumers need to know that, by
law, no meat sold in the United States is allowed to contain drug
residues that violate Food and Drug Administration (FDA) standards.
Additionally, all products approved by FDA for use in food producing
animals must first pass significant human food safety benchmarks.
It is also important to recognize that animal drugs go through a
rigorous, science-based testing process before they are approved for
use. FDA, the U.S. Department of Agriculture (USDA), veterinarians,
animal health companies, producer organizations, and other stakeholders
have implemented several layers of human health protections during the
past decade to reduce any risks associated with antibiotic use in
animals.
FDA approves antibiotics and the specific dosage rates to treat
specific diseases or conditions, and producers are legally required to
follow these precise label directions. This rigorous approval process
was made more stringent in 2003 when FDA finalized an additional safety
measure requiring an antibiotic resistance risk assessment for all new
and existing antibiotics known as Guidance #152 (Guidance for Industry
Part 152).
FDA's Center for Veterinary Medicine (CVM) is responsible for
ensuring that animal drugs are safe, effective, and manufactured to the
highest quality standards. The standards and processes for reviewing an
antibiotic used to treat animals is essentially the same as that for an
antibiotic used to treat humans, except for the fact that animal drugs
have to go through additional food safety assessments that human drugs
do not. Every drug is subject to a safety assessment, efficacy
assessment, and quality or manufacturing assessment before it is
approved.
The safety assessment layer of the approval process requires
sponsors to submit data showing use of the antibiotic is safe for the
human or animal in which it is to be used. The safety assessment for
food animals is more stringent than that for human antibiotics in three
respects:
1. While FDA conducts a risk-benefit assessment for human
antibiotics in which it weighs benefits against risks, there is
no consideration of benefits in the review of antibiotics used
in food animals. This means any animal or human health risks
for products under review must be extremely low since FDA does
not consider any benefits to offset the risks.
2. The safety assessment for food animal antibiotics requires
sponsors to submit human food safety studies to ensure meat
from animals treated with the antibiotic will be safe for human
consumption. Data from these studies are used to establish
withdrawal periods, or the amount of time prior to processing
during which antibiotics cannot be used in order to ensure
there are no residues above tolerance levels in the final food
product.
3. In 2003, FDA implemented an additional safety measure that
``outlines a comprehensive, evidence-based approach to
preventing antimicrobial resistance that may result from the
use of antimicrobial drugs in animals.'' This risk assessment
process was a priority action item in the U.S. Public Health
Action Plan and is required for all newly proposed antibiotics.
Significantly, CVM is working with animal health companies to
also examine all existing, approved products using this new
methodology.
Both the animal and human drug approval processes require efficacy
assessments. This means the submitting company must provide data from
geographically diverse, statistically-designed studies that show the
product will work in the way it is intended to provide a clinical
improvement or cure.
Finally, approval of animal and human drug products require a
quality or manufacturing assessment consisting of facility inspections,
assurance of product stability, adherence to good manufacturing
practices and other procedures to assure FDA the sponsor can
manufacture the product in the approved form.
In addition, USDA's Food Safety and Inspection Service (FSIS)
conducts tests to ensure withdrawal periods are being followed and beef
products entering the food supply do not contain antibiotic levels that
violate FDA standards. The testing protocol for the FSIS National
Residue Testing Program has been updated continuously since its
inception in 1967.
Once the products have been approved, many are used to prevent
animal disease. There are some who will claim that the cattle industry
is dependent on drugs to fix the problems associated with our
production methods. While we prefer to prevent diseases, animal drugs
are just one tool we utilize to control disease. The cattle industry
strives to invent and improve production practices that help minimize
the use of drugs and prevent diseases.
An example of an advance in disease prevention management is the
increasing availability of ``backgrounded'' cattle which have received
appropriate immunizations for bovine respiratory disease and are then
held in local environments to overcome the stress of weaning prior to
being shipped to a feeding facility. These cattle are sold at a premium
due to their reputation for decreased disease occurrence at the feeding
facility.
Another example of management practices reducing the need for
therapeutic intervention is the ``Sandhills Calving System''. Named for
the intense cow/calf production area in the sandhills of Nebraska, this
system involves periodically moving cows which have not yet calved away
to new calving areas and leaving behind the cows and calves which have
recently calved. In this way any shedding of disease organisms and
related disease outbreaks are isolated within a subset of the animals
and prevented from spreading to the entire herd.
The importance of assuring adequate colostrum intake in newborn
calves has been demonstrated repeatedly, including data showing that
inadequate intake can result in differences in health performance as
far removed as in the feedlot phase of beef production. The economic
incentive to pay attention to colostrum intake is now based on more
than just neonatal health on the farm of origin in an industry where
source identity of cattle throughout the production cycle becomes more
common place through alliance programs, retained ownership, and branded
beef programs.
Despite continually advancing management practices, vaccines remain
a staple of preventive programs in cattle. While there are vaccines
with demonstrated field efficacy for some pathogens related to bovine
respiratory disease, we still await vaccines with consistent, proven
efficacy for diseases such as systemic or enteric salmonellosis,
infectious pododermatitis (foot rot), Mycoplasma bovis involved in the
bovine respiratory disease complex, infectious bovine
keratoconjunctivitis (pinkeye), and anaplasmosis. It is crucial that
funding be provided for basic and applied research leading to increased
vaccine availability.
Once a disease has taken hold, we must utilize animal drugs to
control the disease and prevent its spread. Treatments for control of
some cattle diseases have been approved by FDA/CVM. For example, there
are five antimicrobials approved for control of bovine respiratory
disease. When appropriate, these applications are very effective in
decreasing morbidity and death.
Another example of using antimicrobials to control disease is the
occurrence of clinical anaplasmosis in cattle. Anaplasma marginale is a
blood cell parasite that causes loss of red blood cells in cattle due
to infected cells being cleared from the body. In cattle less than 1
year old, the clinical signs are mild due to the animal's ability to
regenerate red blood cells while mounting an immune response. As
animals age, the severity of the disease worsens to include death as a
likely outcome. Chlortetracycline may be fed to cattle at risk for the
disease during and immediately after the vector season to control
clinical signs while allowing infection that results in a carrier
status and immunity to the disease.
Anaplasmosis is a good example in examining the use of the term
``subtherapeutic.'' Chlortetracycline is effective for controlling the
effects of anaplasmosis. The approved in-feed dose for this application
is 0.5 to 2.0 mg/lb of body weight per day in beef and non-lactating
dairy cattle over 700 lbs, and 350 mg per animal per day in beef cattle
less than 700 lbs. In comparison, A dose of 10 mg/lb per day may be
used in the feed for treatment of bacterial pneumonia caused by
Pasteurella multocida organisms susceptible to chlortetracycline.
The point is that the term ``subtherapeutic'' is often interpreted
to mean ``low concentrations'' or ``low dosage''. In the case of
anaplasmosis, a relatively low dose of the antimicrobial is effective
in controlling a disease that can result in suffering and death of the
cattle as well as economic devastation to the producer. The term
``subtherapeutic'' has been defined by some to include growth promotion
and disease prevention claims. I would challenge these groups to define
exactly where a drug becomes ``subtherapeutic'' and therefore incapable
of having an effect on disease. The appropriate use of terms would be
to address the drug use by the label claim of treatment, control, or
increase in rate of weight gain and/or feed efficiency. Where
appropriate, a relatively low dose of an antimicrobial may effectively
control disease signs along with the resulting adverse animal welfare
and economic effects. This relatively low antimicrobial exposure also
minimizes the total exposure of normal and pathogenic bacterial flora
to antimicrobials over time.
The ``subtherapeutic'' categorization attempts to cast all
antimicrobial regimens below an undefined threshold as inappropriate
due to selection of resistant pathogens. In reality, resistant organism
selection pressure is much more complicated than just ``a high
concentration for a short term is good, a lower concentration or a
longer exposure is bad''. The use of the term ``subtherapeutic''
indicates a cursory knowledge of the effects of antimicrobials in food
animals as they relate to the combination of effects on animal well
being, disease control, and food safety. Each application is different,
and the attempts to supersede the regulatory process with blanket
legislation prohibiting ``subtherapeutic'' uses, however well
intentioned, will result in instances where a decreased ability to
address disease pressures in cattle production will not be offset by a
benefit in antimicrobial resistance selection.
I would not propose that the bacterial pathogens in humans and
cattle exist in total isolation from each other, nor would I claim that
there are no possible links between antimicrobial use in cattle and
therapy in humans. However, I would caution that circumventing the
approval process in making leaps from effect back to cause will
undermine the ability of the cattle industry to address disease
challenges and in many cases may result in no benefit to human
therapeutics.
Separate scientific risk assessments have been conducted on the
uses of virginiamycin and macrolides in food animals.\1\ \2\ The former
supported by the FDA/CVM and the latter supported by a pharmaceutical
company. Neither risk assessment defined a risk which any reasonable
reviewer would classify as significant. It is absolutely essential to
the wellbeing of animals and humans in the United States that
discussions on antimicrobial resistance be focused on specific drugs,
uses, and pathogens with appropriate data supporting the discussion.
Efforts to cast all food animal antimicrobial uses in the same light
are both misguided and dangerous.
As Congress continues to have an interest in this issue, we
recommend that the focus be put on the tools already in place rather
than imposing new rules, regulations, and prohibitions on animal
agriculture. One way to do this would be to ensure that the National
Antimicrobial Resistance Monitoring System (NARMS) and the Food Animal
Residue Avoidance Databank (FARAD) be fully supported and funded.
NARMS was developed in 1996 to monitor changes in susceptibility of
select bacteria to antimicrobial agents of human and veterinary
importance and is a collaboration between three Federal agencies
including FDA's CVM, the Centers for Disease Control and Prevention
(CDC), and USDA. NARMS also collaborates with antimicrobial resistance
monitoring systems in other countries, including Canada, Denmark,
France, the Netherlands, Norway, Sweden, and Mexico so that information
can be shared on the global dissemination of antimicrobial resistant
foodborne pathogens.
The NARMS program monitors changes in antimicrobial drug
susceptibilities of selected enteric bacterial organisms in humans,
animals, and retail meats to a panel of antimicrobial drugs important
in human and animal medicine. Bacterial isolates are collected from
human and animal clinical specimens, from healthy farm animals, and raw
product from food animals. Retail meats collected from grocery stores
were recently added to NARMS sampling. A pilot study of animal feed
ingredients collected at rendering plants across the country was also
started in 2002. The CDC and USDA provide the NARMS results annually in
comprehensive summary reports.
The stated goal of NARMS activities is to prolong the lifespan of
approved drugs by promoting prudent and judicious use of antimicrobial
drugs and to identify areas for more detailed investigation.
NCBA feels the program could be improved if the FDA, USDA and CDC
worked more collaboratively; this includes, among other things,
division of funds as well as evaluation of the data. NCBA especially
has concerns in how CDC analyzes and utilizes data. Data analysis
should be purely science-based and without preconceived agendas. There
are various examples of the damage that can be done to industry when
Federal agencies do not cooperatively work together. The cattle
industry cannot afford for Federal agencies to have an unscientific
mis-step that can remove valuable animal health options from our
producers.
The issue of antimicrobial resistance is very concerning to cattle
producers. We encourage and advocate for judicious use of all
medications. In fact, NCBA policy supports the Producer Guidelines for
Judicious Use of Antimicrobials which have been in place since 1987. In
addition, NCBA participates in the Codex Alimentarius task for on
antimicrobial resistance.
Antimicrobial resistance is not a black and white issue. It is a
multi-faceted and extremely complex issue that cannot be solely focused
on the use of drugs in animal agriculture. Unfortunately, animal
agriculture has been a primary target in this fight, with little or no
consideration given by the public to the use, misuse, and mishandling
of human drugs by the general population. To ensure that the issue of
antimicrobial resistance is properly addressed, it is imperative that
we gather accurate, appropriate, and complete data to identify any
problems and all contributing factors. To date, only limited data
exists. These data need to be gathered and scientifically evaluated
without bias or a pre-determined agenda before any further action is
taken by Congress. We need to have strong information on which to base
any action that can impact the use of drugs in animal agriculture.
Related to preventing selection for resistant pathogens is the need
to know the optimal duration of antimicrobial therapy that balances
initial treatment successes, subsequent relapses, and antimicrobial
selection pressure in favor of resistant pathogens. In both human and
veterinary medicine we are lacking critical studies that define optimal
duration of therapy.
FARAD is another valuable tool that Congress and the Administration
have neglected.
Operating since 1982, FARAD is a computer-based system designed to
be utilized by veterinarians and livestock producers in finding
information on drug use and residue problems. During the drug approval
process, FDA establishes drug residue tolerances in order to help keep
food safe. They also establish waiting periods and withdrawal times to
determine how long you must wait for the animal to process and
eliminate the drug from their systems before they can be harvested for
food. The information in this database is invaluable in helping to
avoid drug residue problems and keeping the food supply safe. FARAD
also looks at pesticide and environmental contaminant residue issues.
Unfortunately, the funding for FARAD runs out next week, and unless
Congress adds funding to the continuing resolution, the valuable
information it holds will be gone.
Finally, I would like to talk about the steps the industry has
taken to police ourselves. The Beef Quality Assurance (BQA) program has
set forth recommendations for how cattle producers should use
antibiotics to protect and maintain the health of their animals. BQA
was established in 1987 to provide cattle producers with the principles
and tools to use every day to ensure animals are given proper care and
attention.
BQA unites producers with experts (animal scientists,
veterinarians, feed suppliers, animal health companies, meatpackers,
retailers and state and Federal regulators) to develop management
programs using the latest science and technology to assure proper
animal care, beef quality, and safety. The BQA program provides
guidelines for livestock care and handling, nutrition and veterinary
treatment and incorporates current FDA, Environmental Protection Agency
(EPA), and USDA regulations as well as Hazard Analysis Critical Control
Point (HACCP) principles.
Cattlemen can become BQA certified when they meet criteria for
quality beef production set forth in the BQA guidelines. Producers also
undergo continuous training to remain certified. The BQA Manual is the
overarching guideline that provides consistency across the nation, but
states can go beyond national standards to meet state needs and
opportunities. Most states have individual BQA programs that are
tailored to the needs of their particular state beef industry, and can
offer their own certification standards. State certification
requirements vary, but may include third party verification and testing
procedures to ensure good management practices.
Today, BQA influences more than ninety percent of U.S. cattle.
Approximately 185,000 copies of the brochure of NCBA's Care and
Handling Guidelines have been sent to producers, veterinarians,
Departments of Agriculture, and Universities. BQA is not a static
program. An advisory board made up of cattle producers, beef and dairy
veterinarians, University and Extension scientists, meat scientists,
auction markets, and the transportation industry continually work to
update and strengthen the program. NCBA continues to improve this
scientifically based program in order to meet current and future needs
of our industry in order to maintain a healthy cattle population and a
safe beef supply for our consumers.
In conclusion, we find that in today's cattle industry, the need
for animal health interventions that focus on prevention of disease,
control of disease pressure, and therapy of animals with disease is
critical to the success of cattle producers across this country, as
well as helping to keep our food supply safe. However, our industry
believes that the use of these drugs comes with much responsibility,
and that is why we have worked together with our partners in industry
to educate and train cattle producers. The success of programs such as
BQA shows our industry's commitment. This commitment cannot be
overlooked by those who want to end or restrict the use of animal drugs
without having any credible information to base their accusations. That
is why we urge Congress to turn their efforts towards proven tools such
as NARMS and FARAD in helping to keep our animal and human populations
healthy, and to continue to support the established scientific methods
for drug approval and review as the forum in which to evaluate
antimicrobial use in food animals. Thank you for the opportunity to
testify today and we look forward to working with you in the future.
Endnotes
\1\ Virginiamycin risk assessment. FDA Center for Veterinary
Medicine website, http://www.fda.gov/cvm/CVM_Updates/
virginiamycinup1.htm. Accessed 9-23-08.
\2\ Hurd H.S., Doores S., Hayes D., et al. Public health
consequences of macrolide use in food animals: a deterministic risk
assessment. J. Food Prot. 2004:67(5):980-992.
The Chairman. Thank you. I wish the whole country could
have heard the testimony that you have given this morning, all
of you. I think there will be a lot of comfort and satisfaction
that you are doing your very best to not only have healthy
animals but healthy, safe food.
Somebody may comment, what safeguards do you have to combat
antibiotic residue; anybody? What safeguards do you have?
Dr. Klopp. I will be happy to respond to that one first.
There has been a lot of focus placed on a national animal ID
system. In the chicken industry, we have had an animal ID
system for over 30 years through vertical integration. So the
way we monitor residues is by reports that are in black and
white as far as the use of any antibiotic or intervention that
we use. We document the dates, the dosages, when we started
treatment, when we ended treatment, and this is all documented
in relation to processing and also to make sure that the
appropriate dosages are used. We also, as I am sure every
industry does, we participate through the FSIS residue testing
program, and I also want to compliment Dr. Apley on the fact
that he mentioned the need for funding especially for FARAD.
That needs to happen.
The Chairman. I agree.
Please, go ahead, Dr. Byrne.
Dr. Byrne. Certainly in the dairy industry, we do a very
active job to prevent antibiotic residue starting with
treatment records, much like the rest of the livestock
industry, following appropriate withdrawal times and then
testing every tanker of milk that arrives at a processing plant
to ensure that it doesn't contain animal drug residues. So all
those systems are there to ensure that we do not end up with
any residues in the milk supply.
The Chairman. Thank you.
Anybody else? Dr. Rowles?
Dr. Rowles. I can't speak for every producer, but I can say
that in our operation, we are very, very cognizant of residues.
We have to think about not only U.S. residues but we also have
to think about Japanese residues because we ship about 40
percent of our product overseas. And so we are very, very
cognizant of those issues and make sure that we are physically
removing those products from the site so that there is no
chance of a mistake.
Dr. Rybolt. Mr. Chairman, I would just add that as
mentioned in my testimony, we follow our residue avoidance
program that was developed by the National Turkey Federation
and we also ensure that we follow the prescribed withdrawal
timeframes for the particular antimicrobial to ensure that
there is no residue.
The Chairman. Thank you.
Dr. Apley?
Dr. Apley. Yes. Mr. Chairman, in the feedlot industry, we
routinely work with written treatment protocols that have
withdrawal times incorporated then into them and at the
majority of the feedlots, we have computerized individual
animal records that record the drug given to that animal, the
withdrawal time, and before penned-up cattle can be shipped,
those records are checked, and if we cannot--if we have an
animal that still has a withdrawal in effect and we cannot
identify it, that pen is not shipped until that animal is
identified or clears its withdrawal time.
The Chairman. Anybody else? Well, thank you very much.
I'll just welcome our Committee Chairman to join us here,
Mr. Peterson from Minnesota.
Mr. Peterson. I just want to say, I want to thank you and
the Ranking Member for the outstanding job you are doing
keeping on top of this.
The Chairman. Well, we are trying. Thank you.
Robin?
Mr. Hayes. Gentlemen, I don't know how you could have been
any more thorough. The questions that I was contemplating have
been answered in tremendous detail. Thank you for your
attention to this important subject.
The Chairman. I recognize the gentlelady from North
Carolina, Ms. Foxx.
Ms. Foxx. Thank you. I agree with our Ranking Member, Mr.
Hayes, and I too thank the Chairman and the Ranking Member for
staying on top of this issue.
The Chairman. Well, I appreciate it. Your testimony has
been good. Blair, I have seen your operation and I know that
you go to a great extent, great means, besides the cleanliness,
the way you do things. I think that the public ought to know
that as well, and I am sure that throughout the industry that
you represent that you do that. I have been to several other
locations over the years.
I would like to just throw this question out for any of you
again. If antibiotic medication were prohibited, could current
food demands be met? Dr. Klopp, you kind of made me suspicious
of that in your testimony, but anyway, does anybody want to
make a comment? Do you think we can do it without the
antibiotics?
Dr. Klopp. Well, this industry didn't get where it is, the
only way we get things done is because we get it done. So, yes,
but there would be a huge price to pay both in the availability
of the amount of meat, the cost of the chicken meat, and the
other part that gets a lot of attention is on the microbial
quality of the meat because bacteria are a fact of life. And
the given food safety aspects that would suffer from the lack
of antibiotic interventions would increase, and I do want to
make a comment. There has been a lot of negative statements
made about growth promotion and it has been mentioned here
about subtherapeutics, and the way I look at antibiotics in
feed is, that it is a dosage range for disease prevention. I
don't look at growth promotion. I don't look at
subtherapeutics. I look at a dosage range, and this is how you
control disease. But yes, you don't want to overstate anything,
but there would be tremendous negative implications for the
American public.
The Chairman. I appreciate that.
I think both you and, I believe it was Dr. Rybolt, made a
comment that if we didn't have antibiotics, the volume of
manure and what to do with it environmentally would just
skyrocket. Any comment about that?
Dr. Rybolt. Yes, sir. In my written statement, I stated
that if we did not have the use of antimicrobials in the turkey
industry specifically, what would happen is, we would have a
decrease in feed efficiency so we would have a decrease in
utilization of the nutrients. You would have increased manure
coming out of the birds, to put it bluntly, so therefore you
would have that environmental impact as well and would have to
deal with that.
The Chairman. I appreciate that.
Ms. Foxx. Mr. Chairman, your question has prompted me to
think of one. Could I----
The Chairman. I will get right back to you. I have a line
of thought here and I want to stick with it and I will come
right back to you, Ms. Foxx.
Dr. Rowles, based on your practice of veterinary medicine,
as well as a producer, maybe you could make a comment for us
that we can have in the record about how a veterinarian sits
with a producer and works out their health plan.
Dr. Rowles. Certainly. In the swine industry, the
veterinary profession is very, very actively involved in
developing herd health plans for their operations. First of
all, they look at issues of housing, they look at issues of
biosecurity, they look at issues of management, nutrition,
parasite control. All of those things are taken into account
when decisions are made on how to handle, grow, raise and
manage pigs. The antibiotics that we referred to today are only
one of those tools, but it is a very, very important tool that
we need to make sure that we maintain in that animal health
program development.
The Chairman. Thank you.
Ms. Foxx.
Ms. Foxx. Thank you, Mr. Chairman.
Now, I grew up where we raised chickens running wild, and I
am a huge consumer of eggs and chickens and so is my family.
But, it occurred to me as somebody who tries to think about how
things have changed over time and how we have to weigh the cost
and benefits of change, in 1937, our average lifespan was 59
years. That sticks in my mind because I often talk about Social
Security being implemented. Our average lifespan now is almost
80. So in a very short period of time, our lifespan has changed
dramatically in this country. I don't think--I mean, I am a
social scientist, so I know you can't attribute it to any one
thing. It would seem to me that we have seen a tremendous
change in the way we get our food and the way our food is
processed, the way it is grown. Do any of you know of studies
that have been done, any obscure dissertations out there, that
have looked at causes of illness and death that used to be
created by eating bad meat, eating bad food, and comparing that
with what our situation is now? Was there something done in
years past not even thought about to be compared with now? I am
just not familiar with the literature in this area.
Dr. Rowles. If I may, I may not be answering your question
directly but I think this may speak toward what you are trying
to address. Recently Ohio State did a study where they were
comparing conventionally raised pigs versus antibiotic-raised
pigs, and one of the findings that they found was that the
incidence of things like trichonella, toxoplasmosis, which are
true human potential problems, was higher in the antibiotic-
free pigs, and I should add, Salmonella as well. And so in the
antibiotic-free-raised pigs, the incidence, the percentage of
infected carcasses was higher in antibiotic-free versus
conventionally. We would argue that the conventional production
practices that we are using today are providing a much safer
product than what we produced 10, 15, 20 or 40 years ago.
Ms. Foxx. And Dr. Klopp indicated that also in the comments
that he made about chickens, so I was just curious if there had
been any real extensive work done. Thank you very much.
The Chairman. I would like to offer the opportunity to all
of you on the panel to make any additional comments you would
like to make if you care to at this time.
Dr. Rowles. I would like to add just one further comment.
We talked about the issue of manure, but one other factor in
the efficiency discussions is also the input side on the corn.
Right now we have corn prices that are extremely high, and
industries are struggling in terms of a profitability
standpoint. Not only is there an increase in manure but there
also would be an increased need and demand for corn and/or
soybean meal to produce that extra product at a time when those
prices are at a premium.
The Chairman. Your point is well taken. We are going
through a transition period, but every producer out there that
I know in the corn, soybean production side, I was hoping some
day they might be able to get a better price and now we have to
figure out how to work with it, and we will. I think we are.
But I appreciate your comment. Your point is well taken.
Anybody else? Please.
Mr. Van Zetten. Mr. Chairman, obviously from the testimony
you have heard, to the entire livestock industry, animal health
is very important, and thank you for holding this hearing in
order to allow us to talk about the advances in animal health
and the importance of being able to maintain animal health for
high-quality, safe products for all consumers. Thank you.
The Chairman. You are welcome.
Anybody else?
Dr. Apley. Mr. Chairman, one of the things I would like to
make sure the public realizes is the sophistication with which
we monitor our antibiotic use and treatment results in food
animals. For example, I mentioned the feedlots, and ones that I
work with, with the individually identified animals, we
routinely monitor treatment success, treatment failure rate,
relapses. We look at the case fatality rate, the numbers of
those treated that die. We work on the case definitions for
those and we go back and concentrate very aggressively on how
early we are able to identify cattle with disease to minimize
the need for further treatment. It is really very sophisticated
and I think in the swine industry, I am very familiar with this
and I am sure it is that way in the other industries that are
here today. The level of monitoring that we are at and our
ability to tell you on a daily basis what is going on in our
herds or flocks has come to a point that I am not sure the
public appreciates. I think we would all say we are really
proud of the way we are able to monitor what we are doing with
the tools we have.
The Chairman. I appreciate that comment very much and I
think that what you have done today is a good step in that
direction or an additional step, I might say, and I would
encourage you to keep it up.
We will dismiss the panel at this time and thank you very
much for your testimonies. We appreciate it, and we will take
the liberty to come back to you for further information if we
need it. You are excused at this time and we would invite the
third panel to come to the table.
Mr. Peterson [presiding.] Mr. Boswell had to step out for a
minute, so there is no reason we can't get the panel going, and
welcome to the Subcommittee. I want to welcome Dr. Singer, who
is from my home State of Minnesota. They do an outstanding job
there at the university in monitoring animal health and a lot
of other things, so welcome to the panel. Dr. Carnevale, I
guess you are first. You have 5 minutes, and your full
statement will be made part of the record, so feel free to
summarize.
STATEMENT OF RICHARD A. CARNEVALE, V.M.D., VICE
PRESIDENT, SCIENTIFIC, REGULATORY AND
INTERNATIONAL AFFAIRS, ANIMAL HEALTH INSTITUTE, WASHINGTON,
D.C.
Dr. Carnevale. Thank you, Mr. Chairman and Members of the
Subcommittee. Thank you very much for the opportunity to appear
before you today. My name is Dr. Richard Carnevale and I am a
Veterinarian by training. I am also a Vice President of the
Animal Health Institute, Scientific, Regulatory and
International Affairs. The Animal Health Institute is a trade
association here in Washington that represents the companies
that make medicines and vaccines for animals. Before I worked
for AHI, I spent nearly 20 years with both the Food and Drug
Administration and the U.S. Department of Agriculture working
on animal drugs and food safety.
While I have submitted extensive comments for the record, I
would like to talk to you today about one simple truth, and you
have heard this a number of times on the panel before me:
animals need medicine, including antimicrobials. Without safe
and effective medications to treat, control and prevent
diseases, suffering and death would increase. Additionally,
since healthy farm animals are one of the pillars of safe food,
human health would be threatened by increased animal disease
and increased bacterial loads in foods.
Research-based animal health companies work hard to provide
livestock and poultry producers, and the veterinarians who work
with them, the products needed to keep food animals healthy.
These products must go through stringent science-based review
processes. All products including antimicrobials are required
to meet the same standards as medicines approved for humans,
meaning they must be shown to be safe and effective.
Now, there are several benefits to animals, producers and
consumers from the use of antimicrobials in animal agriculture,
and you have heard this theme before this morning. Animal
welfare is improved as a result of veterinarians and producers
having the tools to protect animal health and keep them
healthy. Producers are more efficient because they can produce
more food with fewer animals. This is especially important in
this market environment that has seen escalating feed costs,
and fewer animals mean less land mass is needed to raise the
number of livestock and poultry to meet current demands. I
think you have heard some very interesting statistics from some
of the producer groups this morning to support that.
There are also benefits to global food markets.
Antimicrobials and other animal drugs that improve animal
health and productivity are critical to American agriculture's
ability to feed the world's growing population. The Food and
Agriculture Organization, FAO, estimates that 75 million more
people worldwide were below the hunger threshold in 2007 as a
result of rising food prices. They propose that one solution is
to help producers raise their output. Finally, consumers
benefit because healthy animals produce safe food. Published
peer-review studies have shown that carcasses from chickens
without subclinical disease that are prevented by antibiotics
are more likely to be free of human foodborne pathogens such as
Salmonella and Campylobacter.
Now, for more than 40 years, there has been an active
debate over the potential for antimicrobial use in animals to
contribute to the human burden of antimicrobial resistance.
Antimicrobial resistance is a serious public health threat, but
I would emphasize that resistance is not a single problem. It
is a problem comprised of several different bacteria-drug
combinations. For instance, some of the most widely recognized
antimicrobial resistance problems in humans are respiratory
tract infections and venereal diseases like gonorrhea. In
neither of these cases is there any evidence that antimicrobial
use in animals is associated with these problems. In a survey
published in 2000, a group of medical experts estimated that
the animal contribution to the overall resistance problem is
likely to be less than four percent. This small contribution
was attributed to the potential for antimicrobials used in food
animals to transfer certain resistant foodborne bacteria like
Salmonella and Campylobacter to humans.
Because of the potential for both antimicrobial-resistant
and antimicrobial-susceptible bacteria to contaminate foods,
our food safety systems are comprised of multiple layers of
protection to guard against this transfer taking place. The
first layer of protection is a stringent regulatory review
process at FDA that you heard Dr. Dunham speak of this morning.
Antimicrobials for use in animals must meet all the same
requirements as antimicrobials used in humans with two
additional important requirements. First, sponsors must show
the drug residues left in meat, milk and eggs are safe for
human consumption. Second, FDA instituted what is called
Guidance #152 several years ago, which outlines a qualitative
risk assessment process that is applied to all antimicrobials
approved for use in animals. The process is designed to
estimate and manage the risk of antimicrobial-resistant
bacteria being transferred from animals to humans.
In addition to the FDA process, there have been several
quantitative risk assessments that have been conducted on
antimicrobial compounds, and they have resulted in findings
that show an extremely low level of risk. A quantitative
assessment is a more detailed review of each step along the
food production continuum from farm to table that could
increase or decrease risks from a hazard such as resistant
bacteria. We believe that risk assessment is the proper tool
for making policy decisions about the use of antimicrobials in
animals. Without this scientific basis for decision-making, we
do run the real risk of making decisions that have unintended
consequences that are damaging to both human and animal health.
A second layer of protection, and one of the most
important, is reducing bacteria contamination in slaughter in
processing plants. Antimicrobial-resistant bacteria represent
only a small subset of bacteria that could contaminate meat and
poultry products. USDA through implementation of the Hazard
Analysis and Critical Control Point system, or HACCP, and
pathogen reduction regulations assures that slaughter plants
are following hygienic procedures to minimize bacterial
contamination. Results have shown that HACCP has worked to
reduce bacterial contamination of meat and poultry products,
and therefore, has reduced antimicrobial-resistant bacteria as
well.
A third layer of protection is comprised of several
monitoring programs established by FDA and USDA to assure
antimicrobials are being used properly and according to labels.
We heard mention of the National Antimicrobial Resistance
Monitoring System, which is a multi-agency program between
USDA, CDC and FDA to monitor antimicrobial-resistant bacteria
in humans, animals and meat products.
A fourth layer of protection is the responsible or
judicious use guidelines. Generally, these guidelines have been
prepared collaboratively between the Federal agencies and
veterinary groups to help assure there is no unnecessary use of
antimicrobials in agriculture. Members of the panel discussed
this previously.
Before I close, I want to note that Congress twice this
year passed legislation dealing with the use of antimicrobials
in animals. The farm bill, passed by this Committee, included a
mandate for additional research on the development of resistant
bacteria in animals and its potential transfer to humans. Then
in the recently enacted Animal Drug User Fee Act, Congress
required FDA to collect data from sponsors on the amounts of
antimicrobials sold for food-producing animals. Our member
companies will of course cooperate with FDA in this endeavor.
Mr. Chairman, there are clear benefits to using
antimicrobials to keep animals healthy including attending to
animal welfare and assuring food safety. FDA has a stringent
review process to assure that antimicrobials used to keep food
animals healthy do not significantly contribute to the burden
of antimicrobial resistance in humans. Monitoring data from
NARMS and several private and public risk assessments
demonstrate that this process is working and that utilizing
important medicines like antimicrobials to protect animal
health provide far more benefits than risk to public health
overall.
Thank you for the opportunity to appear here today and I
welcome any questions from the Subcommittee.
[The prepared statement of Dr. Carnevale follows:]
Prepared Statement of Richard A. Carnevale, V.M.D., Vice President,
Scientific, Regulatory and International Affairs, Animal Health
Institute, Washington, D.C.
Mr. Chairman and Members of the Subcommittee:
Thank you for holding this hearing on recent developments in animal
health. I am Dr. Richard Carnevale. I am a veterinarian by training
with a degree from the University of Pennsylvania and I am here today
on behalf of the Animal Health Institute, a trade association that
represents companies that make medicines for animals. Prior to joining
AHI about 12 years ago, I served as Deputy Director for the Office of
New Animal Drug Evaluation at FDA's Center for Veterinary Medicine and
later as Assistant Deputy Administrator for the Office of Science at
USDA's Food Safety & Inspection Service. AHI companies work to provide
products to livestock and poultry producers that help keep their
animals healthy. By doing this, companies contribute to public health
and food safety. Research shows that the first link in the chain of
producing safe meat, milk and eggs is keeping animals free from
disease.
Food safety starts on the farm, and our companies spend millions of
research and development dollars to find new and innovative products to
keep farm animals healthy. Some animal health products are used to
treat and prevent or control disease in animals. Others help increase
animal productivity, allowing producers to meet the growing world food
demand while minimizing the use of natural resources. More recently,
products are being developed that will contribute to food safety by
reducing bacteria that do not make animals sick but have the potential
to make people sick.
Animal health products are subject to stringent, science-based
review processes at two Federal agencies: pharmaceutical products are
reviewed by the Food and Drug Administration under the Federal Food,
Drug and Cosmetic Act, and biologic products, or vaccines, are
regulated by USDA under the virus, Serum, Toxins and Analogous Products
Act. All products are reviewed for safety and efficacy: Efficacy, which
protects producers by ensuring the products deliver the benefits they
promise; and safety, to ensure the products are safe for the animal
being administered the drug or vaccine and to ensure the meat from the
animal is safe for human consumption and safe for the environment.
One class of products important to the health of food animals is
antibiotics. Antibiotics are used by livestock producers, poultry
producers and the veterinarians who work with them to prevent, control
and treat often fatal bacterial infections. There are many benefits to
animals, producers and consumers that come from the use of antibiotics
in animal agriculture:
1. Animal welfare is improved as a result of veterinarians and
producers having the tools to be able to maintain the animal's
health.
2. Producers are more efficient because they can produce more food
from fewer animals. Without antibiotics to prevent and control
diseases, more animals get sick and die with producers losing
not only the animal but all the input costs, including feed,
that have gone into the animal.
3. There are ecologic benefits. Without antibiotics that improve
weight gains and feed conversion, more land and feed are
necessary to maintain the same herd and flock sizes. Moreover,
some studies have shown that certain antimicrobials used in
cattle feeds reduce levels of methane emissions important as
greenhouse gases.
4. Benefits to global food markets. With the concern over food
costs and availability in today's economic climate,
antimicrobials and other animal drugs that improve animal
health and productivity are critical to American agriculture's
ability to feed the world's growing population. The Food and
Agriculture Organization (FAO) of the United Nations estimates
that 75 million more people worldwide were below the hunger
threshold in 2007 due to increasing food prices. They propose
that one solution is to help producers to raise their output.
5. Consumers benefit because healthy animals are needed to produce
safe food. Over the past 5 years, published, peer-reviewed
studies have indicated that carcasses from chickens without
subclinical diseases are more likely to be free of human
foodborne pathogens.\1\-\4\ Research shows this is
due in part to more standardized carcass size, reducing the
potential for intestinal breakage during mechanical
evisceration.
Antibiotics are approved and labeled for four specific purposes.
1. Disease treatment.
2. Disease prevention.
3. Disease control.
4. Growth promotion, as measured by the amount of feed needed to
produce a pound of animal weight or increased rate of weight
gain.
The first three uses--disease treatment, prevention and control--
are considered to be therapeutic uses by FDA, the American Veterinary
Medical Association (AVMA) and such international bodies as Codex
Alimentarius and the OIE. While critics of antibiotic use like to use
the term ``nontherapeutic'' to refer to disease prevention, disease
control and growth promotion, this term is not used nor recognized in
national or international regulation.
Many assume in-feed uses equate to growth promotion, but this
confuses the use with the route of administration. In fact, any of the
four uses, including therapeutic, can be administered via feed or
water, as that is under certain circumstances the only practical way to
administer medication to large flocks or herds. In most cases, a
veterinarian is involved in this process, recommending feed that is
specifically formulated for the health management system used for the
flock or herd.
How are antibiotics regulated?
Animal health companies rely on a rigorous, efficient, predictable
and science-based review process at the Food and Drug Administration's
Center for Veterinary Medicine (CVM) to provide these products. The
standard for the approval of antibiotics used in animals is the same as
that for antibiotics used in human medicine: They must be shown to be
safe and effective.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The GFI #152 process applies not only to new submissions, but to
all existing products as well. FDA has established a priority list for
the re-evaluation of all antibiotics currently approved and marketed.
Most of the drugs on the list are antibiotics administered in animal
feed for the prevention and control of animal diseases or to increased
the weight gains and improve feed efficiency. The re-review under
Guidance #152 was stimulated by new funding that FDA received and
continues to receive via annual appropriated money specifically
earmarked for these reviews. Bear in mind, though, the evaluation of
these products did not begin with Guidance #152. In response to
concerns raised some 30 years ago, the Bureau of Veterinary Medicine in
FDA, in the 1970's, required sponsors of these products to conduct
tests to determine the potential for resistance to be selected in the
animals and to be transferred to bacteria that could cause human
disease. While the standards and science may have changed over the
years, the safety of these products has been an ongoing exercise at
FDA. Moreover, published quantitative risk assessments performed by
both the agency and individual product sponsors have generally affirmed
that the risks to human health from these antibiotics in animal feed
under approved conditions of use are quite low.
We fully support efforts by the agency to continue to evaluate the
safety of these products using all available scientific data under a
sound risk assessment approach in order to determine the true risk to
public health and guide appropriate risk management interventions to
protect public health.
FDA/CVM has a great deal of authority to act when data or risk
assessments indicate a threat to public health. CVM can--and has--
successfully asked companies to withdraw products voluntarily or to
modify their conditions of use, including restricting extra label use.
The agency can also undertake a notice of proposed rulemaking against a
product, setting in motion a process to rigorously review the science
and determine if a product should continue to be marketed. This
authority has been used to remove antibiotics from the market. Finally,
if the agency determines there is an imminent hazard to public health,
it can immediately remove a product from the market.
In addition to the rigorous review process and the additional
public and private risk assessments that have been conducted, there are
other post-approval layers of protection to ensure the safe use of
antibiotics.
Monitoring programs
USDA's Food Safety and Inspection Service monitor meat samples for
the presence of antibiotic residues as a check on the observance of the
withdrawal times set by FDA. It is very uncommon for FSIS to find an
unsafe residue, an indication that products are being used according to
label directions.
The National Antibiotic Resistance Monitoring System (NARMS) is a
multi-agency program coordinated by FDA to monitor antibiotic resistant
bacteria and allow for implementation of management and control
measures if needed. The three agencies involved are:
The USDA Agricultural Research Service (ARS), which analyzes
Salmonella and Campylobacter isolates collected from carcasses
and meat samples in the USDA FSIS HACCP/Pathogen Reduction
Program for antibiotic resistance;
The FDA, which monitors for resistant bacteria in retail
meats; and
The Centers for Disease Control and Prevention (CDC), which
collects isolates from public health laboratories to monitor
for the emergence of antibiotic resistant enteric pathogens in
humans.
To date, the program has produced 7 years of data representing over
19,000 Salmonella isolates from livestock and poultry carcasses and
meats and 12,000 human Salmonella isolates. Most bacterial species
isolated from humans and tested for resistance against drug classes
potentially related to animal usage have shown stable or declining
resistance to most antimicrobials. Most of the multiple-drug resistance
types, such as Salmonella typhimurium DT104 show stable or declining
prevalence in both food animals and humans since 1996, according to an
expert report issued in 2006 by the Institute of Food Technologists
entitled ``Antibiotic Resistance: Implications for the Food System.''
While AHI strongly supports continued funding of the NARMS program
we would point out that there are inherent weaknesses in the sampling
strategies that prevent the data from estimating a true national
prevalence of resistance and yearly trends. The FDA Science Board has
identified these weaknesses as well and has encouraged the agencies
involved in NARMS to work to improve the data.\5\
Judicious Use Guidelines
Responsible, or judicious, use programs that are specific to
different livestock species give veterinarians and producers specific
guidelines to help them safely and properly use of antibiotics in their
health management systems. Generally, these guidelines have been
prepared collaboratively by FDA, CDC and veterinary groups. These
guidelines help ensure there is no unnecessary use of antibiotics in
animal agriculture. Others testifying today will provide additional
detail on how these principles are used by veterinarians and producers.
There are two additional layers of scrutiny that antibiotic use
receives.
First, at the international level, Codex Alimentarius is
responsible for protecting the health of consumers and ensuring fair
practices in food trade. Codex has established a committee on
antibiotic resistance. Chaired by Korea, this committee is currently
working to establish an internationally recognized process for risk
analysis of antibiotics used in animals. International standards are
important, because bacteria know no borders and actions taken here can
be nullified if there is not concerted international action. It is also
important that the international community establishes a sound
scientific basis for countries to assess the risk of antibiotic use.
Otherwise, government regulators are left open to outside pressure to
take overly zealous precautionary measures that may be unjustified and
in the long term harmful to animal health and food safety.
Second, several risk assessments have been conducted on antibiotic
compounds, and have uniformly found extremely low levels of risk. Some
of these have been conducted and published by the sponsors, some by
independent authorities, and some by FDA. In particular, the FDA risk
assessment on virginiamycin found there were significant differences
between the resistant enterococci bacteria found in animals and those
found in humans. Even after they assumed an association for purposes of
conducting the risk assessment, the levels of risk they estimated were
quite small.
We firmly believe that risk assessment is the proper tool for
making policy decisions about the use of antibiotics in animals.
Without this scientific basis for decision making, we run the very real
risk of making decisions that have unintended consequences that are
damaging for both human and animal health.
Does the Use of Antibiotics in Animals Contribute to Human
Antibiotic Resistance?
There is no question that antibiotic resistance is a serious public
health threat. But resistance is not a single problem: it is a problem
comprised of several different bacteria-drug combinations. For
instance, some of the most widely recognized antibiotic resistance
problems in humans are in respiratory tract infections and venereal
diseases like gonorrhea. In neither of these cases is there any
evidence that antibiotics used in animals are associated with these
problems. In fact, in a survey published in 2000 a group of medical
experts estimated the animal contribution to the overall human
resistance problem is less than four percent.\6\
That small contribution was attributed to the potential for
antibiotics used in food animals to contribute to resistance in certain
bacteria which can be transferred from animal food products to humans.
However, there is a chain of events from the ``farm to the fork'' that
must be traversed by bacteria that develop resistance in animals as
outlined in the accompanying chart:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
While we know this can happen, the question is, how often does this
happen and how severe are the consequences? The answer to this much-
studied question is that it does not happen enough that we can find it
and measure it. So, scientifically, we cannot say it does not happen,
but we can say it is rare.
Finally, there are some recurring questions in the debate about
antibiotic use I would like to address.
First, what is the quantity of antibiotics used in animal
agriculture? Critics have charged that we don't know how big the
problem is because we don't have reliable data about the use of
antibiotics in animal agriculture. However, levels of antibiotic
resistance are not correlated to the amount of use. Not all antibiotics
are alike. Nevertheless, each year AHI surveys its members for the
amount of antibiotics sold for use in animals. Attached to my testimony
are the 2006 results. Note that there are large groupings of products.
This grouping is done because of the small number of companies in the
market and the need to protect confidential business information. The
information is not species specific, because many of the compounds sold
are used in more than one species. While critics have demanded species
specific information, this would only be available if it comes from
producers, adding to their costs and paperwork burden. About 7 years
ago CVM began work on a rule to require data collection but dropped the
effort as a result of these difficulties. Congress recognized this just
this summer when antimicrobial sales and distribution data reporting
requirements were included in the Animal Drug User Fee Amendments of
2008. We are appreciative of the cooperation we received from Members
and staff in working with the Animal Health Industry to craft
appropriate legislative language for these reporting requirements.
Notably, Congress also acted on this issue in the farm bill that
was signed into law earlier this year. That legislation contained an
authorization for USDA's Agriculture Research Service to conduct
additional research to study the development of antibiotic resistant
bacteria in livestock on how judicious use principles can help
producers use these products to protect both human and animal health.
Also, note that we ask sponsors to estimate the amount of
antibiotics used for growth promotion. This estimate dropped to less
than five percent of the total in 2006.
What happens if producers lose access to these products? This
question can be answered with data from the European experiment. In the
late 1990s, the European Union phased out one particular use--the use
of antibiotics for growth promotion. Data from the Danish Government,
which you see on the accompanying chart, shows that use of antibiotics
to treat disease has doubled since the ban.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
In summary, Mr. Chairman, antibiotics are vitally important to the
health of our nation's livestock and poultry herds and flocks.
Antibiotics are highly and vigorously regulated and are used carefully
by veterinarians and livestock and poultry producers. The many
regulatory layers of protection that have been put in place allow us to
use antibiotics to protect both human and animal health and not add to
the burden of antibiotic resistant infections in humans. The FDA
regulatory process and risk assessment are the proper tools for making
decisions about the use of these products, and to make decisions
without these tools we place unwarranted risks on both human and animal
health.
Notes
\1\ Russell S.M. The effect of airsacculitis on bird weights,
uniformity, fecal contamination, processing errors and populations of
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003; 82:1326-31.
\2\ Cox, Jr., L.A. Potential human health benefits of antibiotics
used in food animals: a case study of virginiamycin. Environ. Int.
2005;31:549-63.
\3\ Hurd H.S., et al. Swine Health Impact on Carcass Contamination
and Human Foodborne Risk. Public Health Reports, May-June 2008; 123:
343-351.
\4\ Berrang M.E., et al. Subtherapeutic Tylosin Phosphate in
Broiler Feed Affects Campylobacter on Carcasses During Processing.
Poult. Sci. 2007;86:1229-1233.
\5\ http://www.fda.gov/cvm/Documents/NARMSExecSum03.pdf.
\6\ Bywater, R.J. and Casewell M. An assessment of the impact of
antibiotic resistance in different bacterial species and of the
contribution of animal sources to resistance in human infections. J.
Antimicrob. Chemother. 2000;46:643-635.
Additional References
Phillips I., Casewell M., Cox T., et al. Does the use of
antibiotics in food animals pose a risk to human health? A critical
review of the published data. J. Antimicrob. Chemother. 2004;53:28-52.
Antibiotic Resistance: Implications for the Food System. An Expert
Report, Funded by the IFT Foundation. Comprehensive Reviews in Food
Science and Food Safety 5 (3) , 71-137 doi:10.1111/j.1541-
4337.2006.00004.x.
Hurd H.S. Assessing Risks to Human health from Antibiotic Use in
Food Animals. Microbe 2006;1:115-119.
Hurd H.S., S. Doores, D. Hayes, et al. The public health
consequences of macrolide use in food animals: a deterministic risk
assessment. J. Food Protect. 67:2369-2374.
Wassenaar, T.M. Use of Antibiotic Agents in Veterinary Medicine and
Implications for Human Health. Critical Reviews in Microbiology;
31:1155-169, 2005.
Attachment
News Release
Contact: Ron Phillips
Trends in Sales of Lifesaving Animal Medicines Continue
Washington, D.C., October 3, 2007--U.S. animal health companies
responded to the increased demand for medicine to treat and control
animal disease in 2006, increasing the volume of antibiotics sold for
use in animals in the United States. Antibiotics are critical disease-
fighting medicines used to treat diseases in dogs, cats and other
companion animals, and in farm animals to improve their well-being and
ensure the production of safe and wholesome food.
Continuing a trend observed the past 2 years, the volume of
antibiotics sold to treat, prevent and control disease in animals rose
in 2006, while the percentage sold to promote growth dropped. Total
production for use in animals rose 8.2 percent, according to data
provided by the research-based companies that produce animal medicines.
One factor that may have contributed to the increase was a 2 billion
pound increase in U.S. meat production
The antibiotic data were collected from a survey of members of the
Animal Health Institute (AHI), consisting of companies that make
medicines for pets and farm animals.
``All animal owners rely on these important medicines to fight
disease and keep their animals healthy, whether those animals are cats
and dogs or farm animals,'' said AHI President and CEO Alexander S.
Mathews. ``The careful use of these products contributes to human
health by extending the life of our pets and by helping to provide a
safe food supply.''
Again this year, two classes of compounds, ionophores and
tetracyclines, accounted for most of the increase. Ionophores are
compounds not used in human medicine. All antibiotics undergo a
rigorous approval process at the Food and Drug Administration that
includes an assessment of safety of the product for the treated animal
and safety of the milk and meat produced. In addition, all proposed
antibiotic products as well as those previously approved undergo a risk
assessment procedure, called Guidance #152, to scientifically measure
the safety of the product with respect to health hazards resulting from
the spread of antibiotic resistance.
In 2006, 26.4 million pounds of antibiotics were sold for use in
farm and companion animals, an increase from 24.4 million pounds sold
in 2005. The small percentage of overall production used to enhance
growth dropped slightly to 4.6 percent, down from 4.7 percent the
previous year.
The Food and Drug Administration (FDA) approves antibiotics used in
animals for four purposes: Disease treatment, disease control and
disease prevention, which are considered by FDA and the American
Veterinary Medical Association to be therapeutic, and for growth
promotion.
2006 AHI Survey
Active Antibacterial Ingredients Sold by AHI Members
------------------------------------------------------------------------
2004 2005 2006
Antibiotic Class Pounds Pounds Pounds
------------------------------------------------------------------------
Ionophores, Arsenicals, Bambermycin, 9,602,121 10,293,627 11,149,502
Carbadox and Tiamulin *
Tetracyclines 6,486,207 8,420,250 9,281,703
Cephalosporins, macrolides, 4,176,088 4,417,316 4,496,522
lincosamides, polypeptides,
streptogramins, fluoroquinolones
and other minor classes of
antibiotics **
Sulfonamides and Penicillins 1,117,815 1,043,645 1,198,478
Aminoglycosides 357,077 267,600 327,901
-----------------------------------
Total 21,761,128 24,442,438 26,454,107
------------------------------------------------------------------------
* Ionophores and arsenicals are unique drug products developed for
animal production and not related to traditional antibiotics. Others
in this grouping are therapeutic drugs with limited or no use in human
medicine.
** Grouping necessary to abide by disclosure agreements.
The Chairman [presiding.] Thank you.
Dr. Hoang.
STATEMENT OF CHRISTINE N. HOANG, D.V.M., M.P.H.,
ASSISTANT DIRECTOR, SCIENTIFIC ACTIVITIES DIVISION, AMERICAN
VETERINARY MEDICAL ASSOCIATION, SCHAUMBURG, IL
Dr. Hoang. Thank you, Mr. Chairman and Members of the
Subcommittee for providing the American Veterinary Medical
Association with the opportunity to speak about the advances in
animal health within the livestock industry. My name is
Christine Hoang and I work as an Assistant Director in the
Scientific Activities Division of the AVMA. In addition to
holding a doctorate in veterinary medicine, I also hold a
master of public health with concentrations in veterinary
public health policy as well as epidemiology.
The AVMA as a whole, with nearly 77,000 member
veterinarians, is highly focused on issues related to animal
health, animal agriculture and public health and has committed
extensive resources to their research and evaluation.
Veterinarians are actively involved in research, continually
looking for new and better ways to improve animal and human
health. It is through this same process of careful study that
veterinarians evaluate and determine the efficacy of products
and interventions that safeguard our nation's food supply. With
limited tools, our profession has made many advances in animal
health and food safety in areas such as the development and
implementation of animal disease control programs,
interventions to minimize bacterial contamination, and
biotechnology. Our successes include a decline in foodborne
illness associated with meat and poultry products as well as a
decline in the prevalence of associated foodborne pathogens
including Salmonella and the decreased resistance of these
organisms.
The AVMA supports the use of multidisciplinary and
integrated approaches to address issues affecting public health
and food safety. For instance, in addition to supporting
improved animal husbandry and management practices, we also
support hazard controls in processing and the continued
availability and judicious use of antimicrobials to safeguard
the nation's food supply. Veterinarians also strongly encourage
a veterinarian-client-patient relationship and veterinary
consultation when implementing any treatment regimen.
Dispensing or prescribing a prescription product including
antimicrobials requires a veterinarian-client-patient
relationship. Although there are critical shortages in the
veterinary workforce, veterinarians provide oversight and
advice on the use of medications including over-the-counter
antimicrobials on a significant percentage of animal farms. We
believe that further studies should appropriately address the
availability of veterinary services and that the use of
veterinary services can be improved through the resolution of
the critical shortage of the veterinary workforce.
With the large number of animals produced for food in this
country, the topic of antimicrobial use in food production
often becomes a topic of debate. By controlling and preventing
disease through the judicious use of antibiotics and other
therapeutic agents, veterinarians assist producers in
maintaining and improving animal welfare, the health of the
herd and ensuring a safe food supply.
While the end goal is the same for all medical
professionals--good health--veterinarians are severely limited
in our tools for disease control and prevention. Regulations
for drug approvals are more stringent. Therapeutic agents can
be more difficult to develop, and there are fewer treatments
available. Thus, veterinarians must rely on their knowledge of
clinical medicine to determine the best course of treatment.
Given the numbers of food animal species, in addition to the
diversity of disease conditions that affect animals, a relative
scarcity of labeled indications accompanying FDA-approved drugs
exists. Though the FDA, the AVMA and others have, and continue,
to make significant strides in enhancing drug availability
including legislative initiatives such as the Minor Use and
Minor Species Act, the numbers of FDA-approved drugs are
inadequate to meet veterinary medical needs, placing animal
health and welfare, and potentially human health, at
significant risk.
The Food Animal Residue Avoidance Database, or FARAD, has
been a chronically under-funded program used by veterinarians,
livestock producers, as well as state and Federal regulatory
and extension specialists, to ensure that drug, environmental
and pesticide contaminants are not in milk, eggs and meat that
are consumed by Americans. FARAD serves as an informational
resource for withdrawal times. Withdrawal times are periods of
time when animals and animal products such as milk and eggs are
not to be used for food, allowing time for the animals to
metabolize and eliminate the drugs that had been used for
treatment. The funding lapses of FARAD in 2007, and the
continued lack of recurring support for FARAD, places the
entire program in jeopardy. If funding is not appropriated
before the end of this month, this vitally important asset to
ensure food safety may be forced to close its doors
indefinitely.
The American Veterinarian Medical Association is committed
to ensuring a safe, healthy and abundant food supply and
supports the ongoing scientific efforts and funding for
monitoring and surveillance of foodborne disease and resistant
pathogens, education, development of new antimicrobials,
biologics and other treatment options, and other research to
advance animal health and to better define the challenges
presented by animal agriculture.
Thank you for the opportunity to appear before you today.
[The prepared statement of Dr. Hoang follows:]
Prepared Statement of Christine N. Hoang, D.V.M., M.P.H., Assistant
Director, Scientific Activities Division, American Veterinary Medical
Association, Schaumburg, IL
Thank you, Mister Chairman and Members of the Subcommittee on
Livestock, Dairy, and Poultry, for providing the American Veterinary
Medical Association (AVMA) with the opportunity to speak about the
advances in animal health within the livestock industry.
My name is Dr. Christine Hoang, and I work as an Assistant Director
in the Scientific Activities Division of the American Veterinary
Medical Association. In addition to holding a doctorate in veterinary
medicine, I also hold a master of public health degree with
concentrations in veterinary public health policy, both national and
international, as well as epidemiology.a The majority of my
work focuses upon food safety, zoonotic disease,b and
antimicrobial resistance. As a result, issues related to animal health,
animal agriculture, and human health have not only become topics of
interest, but are topics that require a great deal of intensive
research and evaluation.
The AVMA represents nearly 77,000 U.S. veterinarians engaged in
every aspect of veterinary medicine and public health. As
veterinarians, our oath ethically charges us with promoting public
health and protecting animal health and welfare. Thus, we share many of
the same concerns as our human health counterparts. Among other things,
our members protect the health and welfare of our nation's animals,
help ensure food safety, and protect animal and human health through
prevention and control of zoonotic diseases.
The AVMA supports the use of multidisciplinary and multi-hurdle
c approaches \1\ to address issues affecting public health
and food safety. For instance, in addition to supporting improved
animal husbandry and management practices, we also support the
continued availability and judicious use of antimicrobials to safeguard
the nation's food supply.
The veterinary profession strives to achieve optimal animal health
as well as animal welfare and human health. The fundamentals of food
animal medicine and population medicine d are the same as
the fundamentals of public heath--control and prevention of disease.
While the end goal is the same for all medical professionals--good
health--veterinarians are severely limited in our tools for disease
control and prevention. Regulations for drug approvals are more
stringent, therapeutic agents can be more difficult to develop, and
there are fewer treatments available. Thus, veterinarians must rely on
their knowledge of clinical medicine to determine the best course of
treatment. Given the numbers of food animal species, in addition to the
diversity of disease conditions that affect animals, a relative
scarcity of labeled indications accompanying FDA approved drugs exists.
Though the FDA, the AVMA and others have made and continue to make
significant strides in enhancing drug availability, including
legislative initiatives (such as the Minor Use and Minor Species Act),
the numbers of FDA approved drugs are inadequate to meet veterinary
medical needs, placing both animal health and welfare--and,
potentially, human health--at significant risk.
While it may seem intuitive to some that healthy animals are
critically important for safe food, there are few who understand the
intricacies of why. As an example, it is fairly intuitive that an
effective antibiotic will help decrease the bacterial load in food.
What many do not understand is that it is extremely difficult to
ascertain whether or not a particular animal is carrying certain
bacteria. Many bacteria, such as Salmonella, are shed intermittently,
and cannot be easily detected by routine testing procedures. Animals
can harbor types of bacteria in their intestinal tracts that have no
effect on their health, but can cause illness in humans. Thus, we must
rely on the combination of many different types of interventions to
protect our food supply. These interventions would range from
prevention and control of disease before it occurs in animals to post
harvest interventions such as carcass rinsing to further minimize
bacterial contamination in food. Another concept that is often
misunderstood or overlooked is how seemingly unrelated illness, such as
respiratory disease in a food animal, can affect the presence of
enteric bacterial pathogens in the meat. For example, air sacculitis is
a respiratory disease that affects poultry. It is a fairly common
disease that can spread rapidly and often go undetected until
slaughter. The disease causes tissues to become more friable
e and difficult to remove during food processing. The
increased handling and difficulty in processing increases the potential
for damaging the intestines and contaminating the carcass with enteric
pathogens that can be harmful to humans.\2\ By controlling this disease
through the use of antibiotics and/or other therapeutic agents,
veterinarians assist producers in maintaining a healthy flock and a
safe food supply. This example further illustrates the necessity to
continually maintain and improve animal health in the preservation of
food safety.
Veterinarian's Role
Veterinarians evaluate whether a therapy's benefits would outweigh
its risks to both the patient and to public health. Veterinarians have
been trained to ``do no harm'' as they make therapy recommendations,
and they have the duty to utilize such agents to promote animal health
and welfare in such a way that safeguards the public health. In
addition, veterinarians protect America's food supply by ensuring food
animal health from ``farm to fork,'' including their work in clinical
practice, in state public health agencies, in the Federal Government,
and in the corporate sector. Healthy animals make healthy food; for
veterinarians to be effective in protecting our food supply, the
appropriate tools for preventing, mitigating, and treating disease,
which include antimicrobials, are paramount for veterinarians to be
able to utilize.
Veterinarians are actively involved in research, continually
looking for new and better ways to improve animal and human health.
Some veterinarians work in research through universities, private
corporations, or through government projects, and many are actively
involved in field research. It is through this process that we have
learned so much about the nature of infectious diseases. It is through
this same process of careful study that veterinarians evaluate and
determine the efficacy of products and interventions that safeguard our
nation's food supply. With limited tools, our profession has made many
advances in animal health and food safety, including the development
and implementation of animal disease control programs, pre- and post
harvest interventions, and areas of biotechnology. Other successes
through collaborative efforts include a decline in foodborne illness
from meat and poultry products \3\ as well as a decline in the
prevalence of foodborne pathogens (including Salmonella) associated
with meat and poultry \4\ and resistance of those organisms.\5\ These
are all a result of improvements in animal health and the joint efforts
of stakeholders.
Veterinarians are in the best position to prescribe and administer
the most appropriate therapies for their patients. Veterinarians are
licensed by state authorities to practice veterinary medicine and are
authorized by both state and Federal Government entities to handle
potent medical agents in the course of their professional practice.
While there is governmental and regulatory oversight, veterinarians use
professional judgment to determine the best therapy for their patients:
Specifically, the Drug Enforcement Administration (DEA)
entrusts registered veterinarians to prescribe controlled
substances for animals, i.e., those drugs that are not
available to the general public due to the potential for abuse
and addiction.
The Environmental Protection Agency (EPA) allows
veterinarians to use both restricted-use and conventional
pesticides in the course of their professional practice.
The United States Department of Agriculture (USDA)
recognizes veterinarians as professionals who may vaccinate
animals to advance national animal disease control and
eradication programs.
Of the tools that are available to veterinarians, one of the most
important tools that veterinarians use to protect animal health and
human health is the judicious use of antimicrobials. The continued
availability of safe, effective antimicrobials for veterinary medicine,
including the retention of currently approved drugs and future
approvals of new drugs, are critical components of ensuring a safe food
supply and essential to the improvement of animal health and welfare.
The exact quantity of antimicrobials that are used in animal
agriculture remains unknown and estimates vary greatly depending upon
the source and the classification of antimicrobials. The Union of
Concerned Scientists (UCS) estimates 24.6 million pounds of
antimicrobials were used for non-therapeutic uses (defined by UCS to
include uses for prevention and control of disease as well as for
growth promotion) in cattle, swine, and poultry in 1999.\6\ However,
The Animal Health Institute (AHI) has reported a general downward trend
in total antibiotic use between 1999 and 2004, and estimates 95%
therapeutic use (which includes disease control and prevention),\7\ and
therefore about 1.2 million pounds for growth promotion or feed
efficiency. Antibiotic use estimates are equally confusing and
inconsistent when evaluating human use data. AHI reported in 2000 that
32.2 million pounds of antibiotics are used annually in human
medicine.\8\ However, the UCS estimate for human use (for inpatient and
outpatient disease treatment and as topical creams, soaps, and
disinfectants) was 4.5 million pounds. But the real issue is not the
quantity of antimicrobials that are used but the outcomes of use.
Despite all of these figures and other available data, no one knows
for certain what role animal agriculture plays in the ecology of
antimicrobial resistance. What we do know is that we need to be able to
have as many tools as possible to uphold our oath.
The number and supply of animals that is necessary to keep up with
human demands for animal protein is rapidly increasing. The world's
population is growing, and expected to increase by a third exceeding
nine billion by 2050.\9\ With that population growth, comes an
increased demand for a safe, healthy supply of food. Ban Ki-Moon, the
United Nation's Secretary General, has noted in multiple venues that
global food production must increase by 50% by 2030 to meet those
demands.\10\
In 2000, 9.7 billion animals were slaughtered for human consumption
in the United States. In that same year, the U.S. Census Bureau
reported a population of approximately 281 million. The U.S. population
today is well over 300 million, and the world's population is rapidly
approaching seven billion.\11\ Red meat production alone in the U.S.
totaled 48.8 billion pounds last year.\12\ Today, the European Union's
population is nearly 500 million, but in 2007 slaughtered only 42
million animals for food \13\ compared to the U.S.'s nearly ten billion
animals slaughtered annually. While the United States is often compared
to the European Union in the discussion of differing husbandry and
management practices, few recognize the vast difference in per capita
production and that the United States has the most affordable,
abundant, safe, and healthy food supply in the world.
With the large number of animals produced for food in this country,
the topic of antimicrobial use in food production often becomes a topic
of debate. Much of the discussion revolves around a category of
antimicrobial use commonly known as growth promotion or a group of
antimicrobial uses that are poorly categorized as ``non-therapeutic.''
The term ``non-therapeutic'' has no meaning in Federal regulation or
common usage. The FDA approves antimicrobials for four purposes:
disease treatment, disease prevention, disease control, and growth
promotion/feed efficiency. The FDA does not approve antimicrobials for
``non-therapeutic'' uses. Also, the various organizations and people
who use the term ``non-therapeutic,'' use it inconsistently. For
example, the Pew Commission on Industrial Farm Animal Production
(PCIFAP) provides an unclear definition of ``non-therapeutic'' that is
different than H.R. 962, the Preservation of Antibiotics for Medical
Treatment Act of 2007 (PAMTA). Additionally, the definitions use terms
that are undefined, such as ``routine preventive uses and other routine
uses.'' As a result, the term is not commonly understood. The use of
exclusionary terms, such as ``non-therapeutic'', that are ill-defined
serves to further confuse the issue. We caution against the use of this
term.
Instead, we believe the FDA labeled uses of antimicrobials should
be used as the terminology, i.e., treatment, prevention, control, or
growth promotion/feed efficiency. Alternatively, we advocate using the
definitions of the Codex Alimentarius Commission (an organization of
the World Health Organization and the Food and Agricultural
Organization of the United Nations), the FDA, and AVMA. All three
organizations classify treatment, prevention, and control of disease as
therapeutic uses.
Not all antimicrobials or all their uses are equal in their
probability of developing resistance or creating a risk to human
health. The EU's Scientific Committee on Animal Nutrition has agreed
that possible theoretical human health concerns related to animal
agricultural use of antimicrobials continue to be the focus while
probable and scientifically based benefits to human and animal health
are largely ignored.\14\
There is little debate on the use of antimicrobials for treatment
of disease in animals. However, few understand the importance of
disease control and prevention, and even fewer have a clear
understanding of growth promotants. Prevention and control of disease
are key elements in the practice of veterinary medicine, particularly
in animal agriculture, where the focus is on population health. This
concept of disease prevention and control through herd health is
analogous to public health efforts. Additionally, some of the growth
promoting antimicrobials have no human health equivalent and thus no
human health impact. In fact, studies show a potential health benefit
from the use of growth promoting antimicrobials.\15\-\22\
Danish Experience
The Danish experience has taught us that there can be serious
negative consequences in animal health and welfare following the
withdrawal of growth promoting antimicrobials and few, if any,
improvements or positive human health impact.
In the late 1990s, Denmark instituted a voluntary ban on the use of
antimicrobials for growth promotion (AGPs). (A complete ban of AGPs was
initiated in 2000.) The use of antimicrobials in feed and water for
controlling and treating disease was not banned. The following has been
observed as a result of the ban on the use of antibiotics for growth
promotion in Denmark:
There is little evidence to demonstrate a general decline in
antimicrobial resistance in humans and there is no evidence of
an improvement in clinical outcomes of antimicrobial treatment
of humans, the desired consequence of the antibiotic ban in
livestock. The results have been mixed. In fact, resistance in
humans to some of the banned drugs has increased dramatically.
There has been increased death and disease in the swine
herds, especially at the weaning stage (information inferred
from DANMAP 2005 and other reports on pigs). According to
published news reports, there was a relative increase of 25% in
the number of pigs that died from illnesses from 1995 to 2005.
While the total quantity of antimicrobials used in food
animals has decreased by 27%, the increase in disease has
resulted in a 143% increase in the quantity of antimicrobials
used for therapeutic purposes. And the antimicrobials now used
are classes such as tetracyclines that are also used in
humans.\23\
Resistance to some antibiotics has decreased in some animals
while resistance to other antibiotics has increased
The ban on antibiotic growth promoters in Denmark has not resulted
in a significant reduction of antibiotic resistance patterns in humans.
It has, however, resulted in an increase in disease and death in the
swine herds and an increase in the use of antimicrobials for
therapeutic uses in swine herds that discontinued the use of antibiotic
growth promoters.
Some important resistance trends reported by DANMAP:
Salmonella typhimurium from human isolates f has
shown 34-49% increase in resistance to tetracycline,
sulfonamides, and ampicillin from 1997-2006; increases in
resistance to nalidixic acid and ciprofloxacin were 3.8% from
1997-2006
In contrast, during the same period of time, poultry
isolates have shown only minimal increases (2-6%) in
resistance to the same antimicrobials.
Isolates from pigs have also shown a lesser increase
(25-27%) in resistance to tetracycline and ampicillin than
human isolates during that time.
Campylobacter jejuni from human isolates f has
shown 5-11% increase in resistance to tetracycline, nalidixic
acid, and ciprofloxacin from 1997-2006.
In contrast, during the same period of time, poultry
isolates have shown lesser increases (4-6%) in resistance
to the same antimicrobials.
Enterococcus faecium isolates from healthy human volunteers
has shown no increase in resistance to vancomycin (the
equivalent of avoparcin) from 1997-2006, and remains at 0%.
However, resistance to virginiamycin (quinupristin/
dalfopristin, e.g., Synercid) had been steadily increasing (up
to 25%) from 1997 to 2005 until the definition of resistance
was changed in 2006, bringing the level of resistance down to
0%.g When the definition of resistance is standardized to
the United States definition used by CDC and the level of
resistance in humans in Denmark to Synercid is compared to
the United States, we find that the level is ten times
higher in Denmark in spite of the Danish ban in 1998 of use
in animals and the continued use in the United States.
During the same period of time, Enterococcus faecium
isolates from pigs and poultry has shown 8-20% decrease in
resistance to avoparcin,h virginiamycin,
erythromycin and tetracycline from 1997-2006 (using the same
definition of resistance as the human isolates from 1997-2005)
Even though the results of the Danish experiment with antimicrobial
growth promotant drug bans is very mixed, proposals within the United
States go far beyond the Danish example by proposing to ban uses for
the prevention and control of disease in addition to uses to promote
growth and feed efficiency. Evidence shows that the Danish ban has
caused animal health and welfare problems, without improving human
health.
Based on the results of a limited ban enacted in Denmark (i.e., the
banning of growth promotants, not uses to prevent and control disease),
we do not believe the public would benefit from such limitations on the
use of antimicrobials. The loss of approved uses of antimicrobials will
negatively impact animal health and welfare without significantly or
predictably improving public health. Non-science based, broad bans of
preventive uses of antimicrobials have the potential to harm public
health, such as through increased foodborne disease.
Significant decisions regarding animal health need to be science-
and risk-based decisions. Decisions made without the benefit of
veterinary input as well as a thorough evaluation of risks and benefits
have the potential to further divert resources away from more
appropriate disease control measures.
Actions Advancing Livestock Animal Health
AVMA's Efforts
The AVMA has acted with three objectives in mind:
1. Safeguarding public health,
2. Safeguarding animal health, and the
3. Continued availability of effective therapeutic agents,
including antimicrobials for veterinary medicine and the
retention of currently approved, safe drugs and biologics as
well as future approvals of new therapeutic agents.
Veterinary Oversight, Judicious Use, and VCPRs
Since 1998, the AVMA has actively worked to mitigate the
development of antimicrobial resistance related to the use of
antimicrobials in food animals. The AVMA Guidelines for the Judicious
Therapeutic Use of Antimicrobials were developed to safeguard public
health by providing specific recommendations for responsible and
prudent therapeutic use of antimicrobials. With support and input from
the CDC, Infectious Diseases Society of America, the FDA, and the USDA,
the guidelines were developed in collaboration with our species
specific allied veterinary organizations. These guidelines were based
upon carefully reviewed, scientifically sound research, and we believe
that our members conscientiously adhere to the principles of judicious
therapeutic use of antimicrobials to ensure the protection of human
health, as well as animal health and welfare.
We have actively encouraged and assisted our allied veterinary
organizations to use the AVMA general principles as a template to
develop more detailed guidelines appropriate to each species, disease
and type of client. The AVMA also worked with these groups to develop
and deliver a continuing education program to raise awareness within
the profession and to encourage utilization of the principles.
Fundamentally, the guidelines encourage scientifically based
therapeutic practices, the use of antimicrobials only when needed, and
compliance with all existing regulatory requirements when
antimicrobials are used.
Veterinarians also strongly encourage a veterinarian-client-patient
relationship (VCPR) and veterinary consultation when implementing any
treatment regimen. Dispensing or prescribing a prescription product
(including antimicrobials) requires a VCPR. The VCPR is the basis for
interaction among veterinarians, their clients, and their patients.
The veterinarian must have sufficient knowledge of the animal(s) to
initiate at least a general or preliminary diagnosis of the medical
condition of the animal(s). This means that the veterinarian has
recently seen and is personally acquainted with the keeping and care of
the animal(s) by virtue of an examination of the animal(s), or by
medically appropriate and timely visits to the premises where the
animal(s) are kept.
Veterinarians making treatment decisions must use sound clinical
judgment and current medical information and must be in compliance with
Federal, state, and local laws and regulations. The veterinarian must
also include consideration of: judicious use principles; food safety
and public health; and producer education as a part of the treatment
plan. After considerations have been made for animal, human, and the
environmental health impact, veterinary authorization is required prior
to dispensing of the prescription product.
There are older antimicrobials that are available in medicated
feeds that can be purchased without a veterinary prescription. These
are called over-the-counter or OTC drugs. OTC drugs have been approved
for marketing without a veterinary prescription and include adequate
directions for use under which a lay person can use the drugs safely
and effectively. To our knowledge, no new classes of antimicrobials
have been approved by the FDA as an OTC drug since the 1980s. A newer
category of drugs, the Veterinary Feed Directive (VFD) Drug category,
was created by the Animal Drug Availability Act of 1996 to provide
veterinary control for certain animal pharmaceuticals for use in feed
that are not suitable for OTC status. Any animal feed bearing or
containing a VFD drug shall be fed to animals only by or upon a lawful
VFD issued by a licensed veterinarian in the course of the
veterinarian's professional practice.
Veterinarians must balance the need for animal health and welfare
with the need of human health. We are supportive of measures to
mitigate risks to human health. Risk management measures can include
any of the following: advisory committee review of an existing approval
or application for a new animal drug approval; post-approval monitoring
through systems such as the National Antimicrobial Resistance
Monitoring System (NARMS); limitations on the extent of use (e.g.,
individual animals only for short duration of use); limited or broad
extra-label use restrictions in some cases or all cases; antimicrobial
use through prescription or VFD drugs only; and, finally, non-approval
or withdrawal of a previously approved antimicrobial.
Although there are critical shortages in the veterinary workforce,
particularly in food supply veterinary medicine and veterinary public
health, veterinarians provide oversight and advice on the use of
medications, including OTC antimicrobials, on a significant percentage
of animal operations. Feedlot '99 reports that all large operations and
nearly all (96.5%) small operations used the services of a
veterinarian. Large operations were more likely to use a veterinarian
that made regular or routine visits or employ a full-time veterinarian
on staff than small operations. Conversely, small operations were more
likely to use a veterinarian when the need for one arose. Veterinarian
recommendations had strong or moderate influence on selection of an
antimicrobial for nearly 100% of feedlots. Laboratory test results
influenced 58.8% of feedlots strongly or moderately. Veterinarian
recommendations and laboratory test results were more likely to
strongly influence selection of antimicrobials on large feedlots than
small feedlots. Almost three out of four feedlots provided formal
training in areas related to antimicrobial use.\24\
The USDA Swine 2006 reports approximately seven of ten sites
(69.1%) used a veterinarian during the previous year. A higher
percentage of large and medium sites (88.1 and 85.0%, respectively)
used a veterinarian during the previous year compared to small sites
(60.8%). Nearly five of ten large sites (46.8%) used an on-staff
veterinarian. A similar percentage of large sites (42.5%) used a local
practitioner. Overall, approximately half of the sites (49.5%) used a
local veterinarian during the previous 12 months. About one of four
sites (24.7%) was visited by a veterinarian five or more times.
Producers used the services of a veterinarian for many purposes during
the previous 12 months. A higher percentage of large sites used a
veterinarian for blood testing, production record analysis, employee
education, and quality assurance compared to small sites. For sites
that had at least one veterinary visit during the previous 12 months,
the highest percentage of sites used a veterinarian to treat individual
pigs (63.8%) and to provide drugs or vaccines (62.6%). These are
followed by vaccination consultation (48.6%), quality assurance
(47.9%), blood testing (47.6%), nutritional consultation (19.8%),
environmental consultation (19.0%), and employee training/education
(18.0%).\25\
We believe that these numbers can be improved through the
resolution of the critical shortage of the veterinary workforce by
identifying resources and developing solutions in collaboration with
key stakeholders to ensure that veterinary needs are met. Further
studies should appropriately address the availability of veterinary
services.
Data Collection and Review; Monitoring and Surveillance Systems
The AVMA has also continually advocated for improved, more robust
monitoring and feedback systems for foodborne disease and antimicrobial
resistance such as FoodNet and NARMS. It is unfortunate that reporting
by NARMS is not timelier. For example, the most recent Centers for
Disease Control and Prevention NARMS report that is available to the
public is for 2004--4 years ago.
NARMS data, when combined with FoodNet data, demonstrates that the
case rate of human infections with multi-drug resistant Salmonella spp.
has decreased 49% between the NARMS baseline years of 1996-98 and 2004
(the most current, publicly available human data from NARMS). In
addition, there has been a 65% reduction in the case rate of penta-
resistant Salmonella typhimurium infections. The case rate for
Campylobacter infections in humans that are resistant to ciprofloxacin
have remained constant over that period.\26\
Additional important resistance trends i reported by
NARMS \27\ (Isolates from humans with clinical disease):
Salmonella spp. (non-Typhi)--\1/2\ as likely to be resistant
in 2004 as in 1996
c a highly significant j improvement in susceptibility
k (20% relative increase in susceptibility, from
66.2% in 1996 to 79.6% in 2004)
Salmonella typhimurium--less than \1/2\ as likely to be
resistant in 2004 as in 1996
c a highly significant j improvement in susceptibility
k (60% relative increase in susceptibility
k from 37.9% in 1996 to 60.7% in 2004)
Campylobacter--only 0.03 times more likely to be resistant
in 2004 compared to 1997
c a marginally significant j increase in resistance (2%
relative increase in resistance from 53% in 1997 to 54% in
2004)
c However, Campylobacter was significantly less likely to be
resistant in 2003 when compared to 1997; there was a
significant j improvement in relative resistance
(8.2% decrease from 53% in 1997 to 49% in 2003)
E. coli O157--\1/3\ as likely to be resistant in 2004
compared to 1996
c a highly significant j improvement in susceptibility
k (10% relative increase in susceptibility)
In addition to trends of improved susceptibility, trends
i regarding multi-drug resistance l also showed
improvement:
Salmonella spp. (non-Typhi)--nearly \1/2\ as likely to be
multi-drug resistant l in 2004 when compared to 1996
c a highly significant j improvement (44% relative
decrease) in multi-drug resistance l (decreased
from 27.0% in 1996 to 15.0% in 2004)
Salmonella typhimurium--nearly \1/2\ as likely to be multi-
drug resistant l in 2004 when compared to 1996
c a highly significant j improvement (34% relative
decrease) in multi-drug resistance l (decreased
from 56.2% in 1996 to 37.2% in 2004)
Campylobacter--slightly less likely to be multi-drug
resistant l in 2004 when compared to 1997
c a marginally significant j improvement (10% relative
decrease) in multi-drug resistance l (decreased
from 15.7% in 1997 to 14.1% in 2004)
2 c However, when comparing 1997 to 2003, isolates were half as
likely to be multi-drug resistant l and there
was a highly significant j improvement (46%
relative decrease) in multi-drug resistance l
(decreased from 15.7% in 1997 to 8.5% in 2003)
Most foodborne infections do not require treatment with
antimicrobials. Information shows that there is a decreasing trend of
foodborne diseases, thereby decreasing the potential numbers of
treatments.\28\ The trends of increasing susceptibility/decreasing
resistance mean more successful treatments when needed. This
information indicates that there is not a public health crisis related
to human pathogens that are thought to originate in animals.
We have also advocated for more research to support scientifically
based therapeutic practices, such as epidemiological studies, that
assess the effects of antimicrobial use. In addition, we advocate for
increased resources for the FDA's Center for Veterinary Medicine (CVM)
so the agency can adequately implement its regulatory authority.
We support the scientifically valid and meaningful collection and
review of data for all uses of antimicrobials and other pharmaceuticals
used in humans and animals. We urge that such data be collected in
concert with other data necessary to explain or inform fluctuations in
use, e.g., disease prevalence, regional data, populations of animals,
etc. An example is the USDA program, Collaboration for Animal Health,
Food Safety and Epidemiology, that is attempting to study the use of
antimicrobials on farms correlated with disease occurrence, and the
effects of antimicrobial use on antimicrobial resistance as measured
both on the farm and during processing of the meat from the specific
farm. Unfortunately, the program has not received adequate funding and
is therefore not completed or ongoing.
The AVMA provided start-up funding for projects to create a
nationally coordinated laboratory system to test for and report on
resistance in animal pathogens and to create a decision support system
to assist veterinarians when making antimicrobial use decisions.
Unfortunately, while this project received follow-on funding by the
FDA, it has not been sustained or completed.
The FDA Role and Actions
The FDA approves antimicrobials for four purposes:
1. Treatment of disease,
2. Prevention of disease,
3. Control of disease, and
4. Growth promotion or feed efficiency.
The first three uses are classified as therapeutic uses by the FDA,
the AVMA, and Codex Alimentarius Commission (an organization of the
World Health Organization and the Food and Agricultural Organization of
the United Nations), and the fourth has also been shown to have health-
promoting effects.
The FDA process for the evaluation of food animal antimicrobials is
at least as stringent as, and often more stringent than, the approval
process for human antimicrobials. In addition to the testing for
efficacy and safety to the individual (human or animal) receiving the
drug that is common to the human and animal drug approval process, each
food animal antimicrobial undergoes an assessment for human and
environmental safety as part of the review by the FDA. The FDA's Center
for Veterinary Medicine uses a very strict safety assessment approval
process that requires sponsors to submit data proving the antibiotic is
safe for both humans and animals. This is a zero-risk procedure for
human safety--benefits to animals are not weighed to offset risks to
humans, but rather, drugs that possess risks beyond ``a reasonable
certainty of no harm'' to human health are rejected.
Another safety measure was instituted in 2003 (Guidance for
Industry #152, ``Evaluating the Safety of Antimicrobial New Animal
Drugs with Regard to Their Microbiological Effects on Bacteria of Human
Health Concern,'') that outlines a comprehensive, evidence-based
approach to preventing the emergence and selection of antimicrobial-
resistant bacteria that may adversely affect human health. The Guidance
requires antimicrobial manufacturers to provide information to the FDA
showing that a proposed animal drug will not harm public health. The
current FDA risk assessment on a drug-by-drug basis provides a
scientifically sound process to protect human health. In the event that
a determination is made that human health is jeopardized, FDA will not
approve the antimicrobial or may limit the use of the antimicrobial in
order to mitigate the adverse effect.
We support GFI #152 while recognizing that it is very conservative
in ensuring that preference is given to protection of human health
without consideration of benefits to animal health and welfare. We also
recognize that the ranking of antimicrobial drugs according to their
importance in human medicine adds additional difficulty for approving
animal drugs because the ranking design includes treatment of human
diseases that are not in any manner associated with food animals. These
diseases include gonorrhea, tuberculosis caused by Mycobacterium
tuberculosis, neurosyphillis, meningitis, neutropenic fever, and
Legionnaire's disease.
In addition, we also recognize that the design of GFI #152 makes it
extremely difficult or impossible for FDA to approve antibiotics for
use in feed or water for treatment of groups of animals if those
antibiotics are also used in humans. This is because the extent-of-use
limitations table assigns a high ranking for intended administration to
flocks or herds of animals regardless if the duration of use is short
(less than 6 days) or long (more than 21 days).
Since the mid-1990s, the FDA has coordinated the NARMS in
cooperation with the CDC and the USDA. NARMS is a multi-agency program
that includes monitoring for resistant bacteria in retail meats by the
FDA, monitoring for resistant foodborne pathogens in humans by the CDC,
and monitoring for resistant bacteria in animals on farms and animal
products in slaughter and processing facilities by the USDA. NARMS has
provided a great deal of useful information since 1996.
Therefore, the AVMA does not believe that the FDA needs new
authority to regulate the human safety of animal drugs. Instead, the
FDA needs additional resources to fulfill its existing mission.
The USDA Role and Actions
USDA Animal and Plant Health Inspection Services (APHIS) regulates
veterinary biologics (vaccines, bacterins, antisera, diagnostic kits,
and other products of biological origin) to ensure that the veterinary
biologics available for the diagnosis, prevention, and treatment of
animal diseases are pure, safe, potent, and effective. According to the
USDA, which regulates vaccines and other biologics for animals, over 80
billion doses of approved vaccine were produced last year.\29\
USDA also has oversight over many national programs for animal
health monitoring and surveillance. Veterinarians in both public and
private practice actively participate in these national programs and
AVMA has consistently advocated for funding to maintain and continually
improve all of these programs.
National Programs
National Animal Health Surveillance System (NAHSS) (http://
www.aphis.usda.gov/vs/nahss/)--NAHSS integrates animal health
monitoring and surveillance activities conducted by many Federal and
state government agencies into a comprehensive and coordinated system.
U.S. status for reportable diseases (http://
www.aphis.usda.gov/vs/nahss/disease_status.htm) as reported to
the World Organization for Animal Health (OIE)
NAHSS Outlook (http://www.aphis.usda.gov/vs/ceah/ncahs/nsu/
outlook/index.htm)--Articles on U.S. animal health surveillance
issues and developments.
National Animal Health Monitoring System (NAHMS) (http://
www.aphis.usda.gov/vs/ceah/ncahs/nahms/)--National studies on animal
health and health management practices of U.S. livestock and poultry.
National Animal Health Reporting System (NAHRS) (http://
www.aphis.usda.gov/vs/ceah/ncahs/nahrs/)--Information on the presence
of reportable animal diseases in the United States.
National Animal Identification System (NAIS) (http://
animalid.aphis.usda.gov/nais/index.shtml)--This program coordinates and
expands animal identification programs and practices in livestock and
poultry.
National Animal Health Laboratory Network (NAHLN) (http://
www.aphis.usda.gov/vs/nahln/)--This network of state animal health
laboratories provides, among other things, laboratory data to meet
epidemiological and disease reporting needs.
National Poultry Improvement Program (NPIP) (http://
www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/index.shtml)--
National poultry health monitoring and surveillance.
National Aquaculture Program (NAP) (http://www.aphis.usda.gov/
animal_health/animal_dis_spec/aquaculture/index.shtml)--National
aquaculture health monitoring and surveillance.
U.S. Animal Health and Productivity Surveillance Inventory (http://
www.aphis.usda.gov/vs/nahss/inventory.htm)--Search for surveillance
programs, studies, and related information.
Impact Assessments on Animal Health Events (http://
www.aphis.usda.gov/vs/ceah/cei/taf/current_iw.htm)--Reports on trade
and production impact of animal disease occurrences in the U.S. and
foreign countries.
Emerging Animal Disease Notices (http://www.aphis.usda.gov/vs/ceah/
cei/taf/emergingdiseasenotice_files/notices.htm)--Information sheets on
new and emerging animal diseases.
National Surveillance Unit (http://www.aphis.usda.gov/vs/ceah/
ncahs/nsu/index.htm)--organization within APHIS tasked with
coordinating activities related to animal health surveillance.\30\
FARAD Role and Actions
The Food Animal Residue Avoidance Databank (FARAD) program was
developed by pharmacologists and toxicologists at the university of
California, Davis, University of Florida, North Carolina State
University and the University of Illinois as a complement to the USDA
Food Safety and Inspection Service (FSIS) Residue Avoidance Program
(RAP) to reduce the rate of animal residue violations through
education, and residue mitigation rather than enforcement.
Whenever drugs are used to treat sick animals or prevent disease or
when animals are exposed to chemicals in the environment, there is a
potential that remnants of the drugs can be found in the meat or other
animal products (often known as residues). The FDA establishes
tolerances for drug residues to insure food safety. The FDA also
establishes ``withdrawal times'' or ``withholding periods'' which are
times after drug treatment when milk and eggs are not to be used for
food, and during which animals are not to be slaughtered. This allows
time for the animals to metabolize and eliminate the drugs that had
been used for treatment.
FARAD personnel collate residue avoidance information from many
sources. These data are then reviewed by residue experts to insure
accuracy and consistency, and further analysis is done by FARAD
personnel at North Carolina State University to explore novel ways in
which the data may be used to prevent residue problems. FARAD maintains
an up-to-date computerized compilation of:
Current label information including withdrawal times on all
drugs approved for use in food animals in the United States and
on hundreds of products used in Canada, Europe and Australia.
Official tolerances for drugs and pesticides in meat, milk,
and eggs.
Descriptions and sensitivities of rapid screening tests for
detecting chemical residues in meat, milk, and eggs.
Data on the fate of chemicals in food animals.
FARAD has been a chronically under-funded resource used by
veterinarians, livestock producers, and state and Federal regulatory
and extension specialists to ensure that drug, environmental, and
pesticide contaminants do not end up in meat, milk, and eggs. AVMA has
been a strong supporter of FARAD and has worked diligently with
Congress on the 2008 Farm Bill to include authorization for a $2.5
million annual appropriation for the Food Animal Residue Avoidance
Databank from 2008 through 2012.\31\ However, if funding is not
appropriated before September 30, 2008, this vitally important asset to
ensure food safety may be forced to close its doors--permanently. Not
only does FARAD ensure the safety of our meat, milk, and eggs, but the
U.S. researchers from FARAD launched a global FARAD (gFARAD) initiative
in response to an increasing need from foreign countries for residue
data and requests made to FARAD to duplicate this successful program in
other countries.
FARAD's efforts in establishing gFARAD have, to date, been financed
entirely by local funds in participating countries, and in the U.S. by
private donations and use of facilities made available by the three
U.S. Universities housing the FARAD program. These exciting
developments, which have attracted collaborations (but no funding) from
the Food and Agricultural Organization (FAO) and Commonwealth
Agricultural Bureaux International (CABI), have far reaching
implications for the safety of foods imported into the United States as
well as upon global food safety and the harmonization of standards and
procedures. Since 2003, the United Kingdom, France, and Spain have
initiated gFARAD sites. The Canadian gFARAD became fully operational
with significant, recurring support from the government of Canada in
2003. In recent years, FARAD has provided training in gFARAD techniques
and databases for China, as well as hosted the Taiwanese gFARAD
consortium and South Korean delegate visits to FARAD.
The funding lapses of U.S. FARAD in 2007 and the continued lack of
recurring support for U.S. FARAD places the entire program in jeopardy.
In addition, the lack of continued funding and support compromises U.S.
leadership in the continued development of a program initiated by our
own researchers. In 2007, gFARAD may have been able to assist in
mitigating the Chinese melamine crisis, however, it was a necessity for
funds to be utilized to maintain essential personnel and no funds were
available for U.S. FARAD to leverage the gFARAD consortium. Global food
safety and security will continue to be a concern for decades to come.
Support for a strong U.S. FARAD is a critical investment in continuing
relationships with our trading partners and global information sharing
between governments to mitigate agroterrorism concerns and ensure a
safe, abundant food supply.
Risk Assessments/Human Health Impact
Antibiotics as a Tool To Prevent and Control Disease in Animals and
Humans
The use of drugs in animals is fundamental to animal health and
well-being. Antibiotics are needed for the relief of pain and suffering
in animals. For food animals, drugs additionally contribute to the
public health by helping keep animals healthy and thereby keeping
bacteria from entering the food supply. The hypothesis, supported by
scientific information, is that a reduction in the incidence of food
animal illness will reduce bacterial contamination on meat, thereby
reducing the risk of human illness.\32\-\39\
Several risk assessments have been performed that demonstrate a
very low risk to human health from the use of antimicrobials in food
animals, and some of the models predict an increased human health
burden if the use is withdrawn. The unique farm-to-patient risk
assessment performed by Hurd demonstrates that the use of tylosin and
tilmicosin in food animals presents a very low risk of human treatment
failure because of macrolide resistance, with an approximate annual
probability of less than 1 in 10 million with Campylobacter infections
and approximately 1 in 3 billion E. faecium infections.\40\ Cox
performed a quantitative human health risks and benefits assessment for
virginiamycin and concluded that there would be a significant human
health risk if virginiamycin use is withdrawn. There would be 6,660
excess cases per year of campylobacteriosis, which far outweighs the
0.27 per year reduction of cases of streptogramin-resistant and
vancomycin-resistant E. faecium (VREF) resulting from the
withdrawal.\41\ Cox also performed a risk assessment regarding
macrolide and fluoroquinolone use and concluded that withdrawal is
estimated to cause significantly more illness days than it would
prevent.\42\ Cox also examined the impact of the use of penicillin-
based drugs in food animals on penicillin/aminopenicillin resistant
enterococcal infections and concluded that not more than 0.04 excess
mortalities per year (under conservative assumptions) to 0.18 excess
mortalities per year (under very conservative assumptions) might be
prevented in the whole U.S. population by discontinuing current use of
penicillin-based drugs in food animals. The true risk could be as low
as zero.\43\ This equates to one potentially preventable mortality in
the U.S. population roughly every 7-25 years. Alban's risk assessment
concluded that the risk associated with veterinary use of macrolides in
Danish pigs resulted in a low risk to human health.\44\
Others have estimated that risk management strategies that focus on
eliminating resistance are expected to create < 1% of the public health
benefit of strategies that focus on reducing microbial loads in animals
or on foods.\45\ In another paper, the authors concluded, ``We came to
some surprising conclusions that were robust to many uncertainties.
Among these were that antimicrobials that benefit animal health may
benefit human health, while regulatory interventions that seek to
reduce antimicrobial resistance in animals may unintentionally increase
illness rates (and hence antimicrobial use and resistance rates) in
humans. . . . In conclusion, our analysis suggests that the
precautionary-principle approach to regulatory risk management may
itself be too risky.'' \46\
Information derived from studies of organic or antibiotic-free
production practices compared to traditional production practices is
inconclusive, but there are indications that organically grown meat may
have less-resistant organisms but greater prevalence and quantities of
pathogens on the meat. Therefore, the greater risk of foodborne illness
is somewhat offset by an increased likelihood of treatment success if
treatment is necessary.\47\-\50\
The question of what the nature and magnitude of the risk to humans
is can only be answered by performing systematic risk assessments. Such
risk assessments must include identification of the endpoints of
concern (e.g., increased illness or mortality caused by bacteria
resistant to antibiotics used to treat the disease in humans), the
nature of the treatment protocols in food animals, the potential routes
of exposure, characterization of the population at risk, and the
probability of occurrence.
Just as in humans, resistant bacteria can and do develop in
animals. However, many of the important details regarding the transfer
of that resistant bacteria, or even resistance genes--to the
environment or humans--still remains in question. Simply because
resistance exists in animals, it does not necessarily equate to a human
health risk. First, the bacteria or its resistance determinants may not
effectively transfer to humans through the food chain. Second, the
pathogen may not colonize in humans to create a foodborne disease.
Third, if a disease does occur, antimicrobial therapy may not be
needed, and the disease resulting from the resistant bacteria is in
effect no different than any other bacteria. In the majority of cases,
treatment is not needed. Supportive therapy, such as fluids, is the
only treatment that is needed for most Salmonella, Campylobacter and E.
coli infections. In fact, antimicrobial therapy of E. coli O157
infections is contra-indicated because such treatment makes the effects
of the disease worse. Last, if antimicrobial therapy is needed, the
pathogen may be susceptible to the drug of first choice. The Therapy
Guidelines for Enteric Infections for non-typhi Salmonella are, ``In
uncomplicated infections antimicrobial therapy is not indicated because
it has no effect on clinical illness and prolongs carriage and
excretion of the organism. . . . Treatment recommended only for young
infants (< or = 6 m) and immunocompromised individuals. Resistance is
common. Agents that can be used include a fluoroquinolone or a third-
generation cephalosporin such as ceftriaxone for 5-7 days. Ampicillin
and co-trimoxazole can be used if the infecting organism remains
susceptible.'' \51\ NARMS \52\ reports the following resistance
percentages of non-typhi Salmonella to fluoroquinolone
(ciprofloxacin)--0.2%, third-generation cephalosporin (ceftriaxone)--
0.6%, ampicillin--12.0%, and co-trimoxazole (trimethoprim-
sulfamethoxazole)--1.8%. These resistance levels do not indicate a
public health crisis associated with foodborne Salmonella.
Conclusion
The American Veterinary Medical Association is committed to
ensuring a safe and healthy abundant food supply. Among other things,
our profession is dedicated to improving animal health, further
safeguarding public health and food safety, and to maintaining the
long-term effectiveness of antibiotics. The AVMA established a
profession-wide initiative to create and implement judicious use
guidelines for the therapeutic use of antimicrobials by veterinarians,
and we launched an educational campaign to raise the awareness of the
profession to the issue. Today, we continue to review and update those
guidelines to reflect current practices and actively encourage
compliance.
Foodborne illness and the spread of antibiotic resistance is a
public and animal health concern. There is no question that the public
demands a safe food supply and that the human medical profession is
facing extreme challenges because of hospital- and community-acquired
resistant human pathogens. The human medical problem with resistant
nosocomial and community-acquired infections has increased the concern
of possible development of resistant pathogens in animals that could be
transferred to humans through the food supply or environment.
The AVMA shares the concerns of the human medical community, the
public health community, governmental agencies, and the public
regarding the potential problem of resistant foodborne pathogens
developing in animals and then being transferred to humans. However, we
emphasize the importance and primacy of using these medicines to
prevent and treat diseases before they enter our food supply. Pre-
emptive bans of veterinary antimicrobials before science-based studies
and risk-based evaluations are performed would be detrimental to animal
and human health. Inappropriate reactions to a perceived problem could
have unknown and unintended consequences that negatively affect animal
health and welfare, and ultimately, could create other public health
risks, such as increased foodborne illness.
The AVMA does not believe that additional regulation of the uses of
antimicrobials or other therapeutic agents in veterinary medicine and
animal agriculture are necessary. Additional legislation and further
regulation can put animal health and welfare and public health at risk.
The FDA has adequate authority for oversight but lacks the resources to
accomplish its many priorities.
An analysis that compared the regulatory strategy of the European
Union to ban or restrict animal antibiotic uses with the United States'
approach of continued prudent use to prevent and control animal
infections, together with measures to improve food safety, has some
pertinent conclusions. Among these, prudent use of animal antibiotics
may actually improve human health, while bans on animal antibiotics,
intended to be precautionary, inadvertently may harm human health.\53\
The AVMA supports the ongoing scientific efforts of monitoring and
surveillance of foodborne disease and resistant foodborne pathogens;
education; development of new antimicrobials, biologics, and other
treatment options; and other research to better define the challenges
presented by animal agriculture. Increased data collection and
surveillance of disease, as well as continued veterinary input
(including the appropriate use of pre- and post-harvest interventions,
and compliance with judicious use guidelines for veterinarians and
producers), may be sufficient to protect human health against the
current small risks without compromising the health of food animals.
We also support adequate funding for all efforts to improve animal
health and food safety, including efforts to combat antimicrobial
resistance. These efforts were high-priority tasks in the 2001 version
of the Public Health Action Plan to Combat Antimicrobial Resistance
that was created by a Federal Interagency Task Force on Antimicrobial
Resistance. The Action Plan reflected a broad-based consensus of
Federal agencies and stakeholders on actions needed to address
antimicrobial resistance and provided a blueprint for specific,
coordinated Federal actions that included the full spectrum of
antimicrobial use: human medicine, veterinary medicine and animal
agriculture. We are disappointed that the Action Plan was not
adequately funded and prioritized by Congress. We are also concerned
that the new Action Plan under development appears to not be as
collaborative, broad-based or acceptable to the diverse community of
stakeholders.
The AVMA is committed to working in concert with the CDC, FDA, and
USDA to provide consumers--not only in the United States, but all over
the world--with the safest food possible. The judicious use of
antimicrobials is but one of the essential components of the process
that enables animal agriculture to meet that demand. Other components
include veterinary care, good management practices, biosecurity, proper
nutrition and good husbandry.
Thank you for the opportunity to appear before you today and speak
on behalf of our profession.
References
a Epidemiology is a medical discipline that is the study
of the causes, distribution, and control of disease in populations and
serves as the foundation and logic of interventions made in the
interest of public health and preventive medicine.
b Zoonotic diseases are diseases that can be transmitted
from animals to humans. CDC estimates at least 60 percent of all human
diseases and 75 percent of all newly emerging diseases are zoonotic.
c The multi-hurdle concept refers to the interaction of
factors that affect microbial behavior in foods. Under some
circumstances these effects are additive. Under others the implication
is that synergistic interactions lead to a combined effect of greater
magnitude than the sum of constraints applied individually.
d Population medicine is a medical discipline focusing
on the concepts of public health and epidemiology. In veterinary
medicine, these concepts are incorporated to make strategic decisions
to advance animal and herd health.
e Friable is a term used in pathology to describe
tissues that are brittle, fragile, and easily damaged.
f Domestically acquired clinical cases.
g The rationale for this change is unknown, but appears
to introduce bias in reporting. DANMAP decided to use a preliminary
European Committee on Antimicrobial Susceptibility Testing breakpoint
instead of the previously used breakpoint established by the Clinical
and Laboratory Standards Institute.
h Avoparcin has never been approved for use in the
United States.
i Odds ratios were calculated based upon available data
from NARMS assuming the reported isolates were representative of the
bacterial population.
j ``Marginally significant'' indicates a p-value between
0.05 and 0.10; ``significant'' indicates a p-value between 0.01 and
0.05; ``highly significant'' indicates a p-value of less than 0.01.
k No resistance detected to any of five subclasses of
antibiotics.
l Resistant to two or more antibiotic subclasses.
Endnotes
\1\ McMeekin, T.A., Presser, K., Ratkowski, D. Ross, T., Salter,
M., Tienungoon, S. Quantifying the hurdle concept by modelling the
bacterial growth/no growth interface. International Journal of Food
Microbiology (http://www.sciencedirect.com/
science?_ob=PublicationURL&_tockey=%23TOC%235061%
232000%23999449998%23178169%23FLA%23&_cdi=5061&_pubType=J&view=c
&_auth=y&_acct=C000069188&_version=1&_urlVersion=0&_userid=6040261&
md5=e025060af42d4f943d833909a70485dc). Volume 55, Issues 1-3, 10 April
2000, Pages 93-98.
\2\ Russell S.M. The effect of airsacculitis on bird weights,
uniformity, fecal contamination, processing errors, and populations of
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
\3\ CDC. FoodNet. Facts and Figures related to ``Preliminary
FoodNet Data on the Incidence of Infection with Pathogens Transmitted
Commonly Through Food--10 States, United States, 2007'' published in
the Morbidity and Mortality Weekly Report (MMWR) on April 11, 2008.
(Available at http://www.cdc.gov/foodnet/factsandfigures.htm)
\4\ United States Department of Agriculture, Food Safety Inspection
Service. Progress Report on Salmonella Testing of Raw Meat and Poultry
Products, 1998-2001.
\5\ CDC. National Antimicrobial Resistance Monitoring System:
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
\6\ Mellon M., Benbrook C., Benbrook K.L. 2001. Hogging it:
estimates of antimicrobial abuse in livestock. Cambridge: UCS
Publications.
\7\ [AHI] Animal Health Institute. 2005. Antibiotic use in animals
rises in 2004. News release. Washington, D.C.: AHI.
\8\ [AHI] Animal Health Institute. 2000. Survey indicates most
antibiotics used in animals are used for treating and preventing
disease. Press release., Washington D.C.: AHI.
\9\ United Nations. Department of Economic and Social Affairs.
Population Division. (12 October 1999). The World at Six Billion. ESA/
P/WP.154. (Available at: http://www.un.org/esa/population/publications/
sixbillion/sixbilcover.pdf).
\10\ United Nations. Department of Public Information. News and
Media Division. (3 June 2008). Food production must rise by 50 percent,
Secretary-General tells Rome high-level conference, stressing that
crisis is chance to revisit past policies. (Available at http://
www.un.org/News/Press/docs/2008/sgsm11612.doc.htm).
\11\ United States Census Bureau. Population Division. (2008) U.S.
and World Population Clocks. (Available at http://www.census.gov/main/
www/popclock.html).
\12\ United States Department of Agriculture. National Agricultural
Statistics Service. (24 July 2008). Livestock and Animals--Slaughter
Statistics. (Available at: http://www.nass.usda.gov/QuickStats/
indexbysubject.jsp?Text1=&site=NASS_MAIN&
select=Select+a+State&Pass_name=&Pass_group=Livestock+%26+Animals&Pass
_subgroup=Slaughter).
\13\ EuroStat, European Commission. Luxembourg: Office for Official
Publications of the European Communities, 2008. (Available at: http://
epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-ED-08-001/EN/KS-ED-08-
001-EN.PDF).
\14\ Phillips I. et al. Does the use of antibiotics in food animals
pose a risk to human health? A critical review of published data. J. of
Antimicrobial Chemotherapy 2004: Vol. 53, pp. 28-52.
\15\ Singer R.S. Modeling the Relationship between Food Animal
Health and Human Foodborne Illness. Prev. Vet. Med. 2007; 79: 186-203.
\16\ Russell S.M. The effect of airsacculitis on bird weights,
uniformity, fecal contamination, processing errors, and populations of
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
\17\ Russell S.M. Ban Antibiotics In Poultry? [Why The Policymakers
Have It Wrong], WATT Poultry/USA, March 2003.
\18\ Dawe J. The Relationship between Poultry Health and Food
Safety. Poultry Informed Professional 2004; 77:1-6.
\19\ Cox L.A., Ricci P. Causal regulations vs. political will: Why
human zoonotic infections increase despite precautionary bans on animal
antibiotics. Environ. Int. 2008 (in press).
\20\ Cox L.A., Popken D.A. Quantifying Potential Human Health
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in
Chickens. Risk Analysis 2006; 26:135-146.
\21\ Cox L.A. Potential human health benefits of antibiotics used
in food animals: a case study of virginiamycin. Environ. Int. 2005;
31:549-63.
\22\ Hurd S. et al. Potential Human Health Implications of Swine
Health, Abstract of Oral Presentation, 2007.
\23\ DANMAP 2006. Use of antimicrobial agents and occurrence of
antimicrobial resistance in bacteria from food animals, foods and
humans in Denmark. ISSN 1600-2032. (Available at www.danmap.org).
\24\ United States Department of Agriculture. Animal and Plant
Health Inspection Service. (May 2000). Feedlot '99--Part I: Baseline
Reference of Feedlot Management Practices, 1999. (#N327.0500). Fort
Collins, CO: USDA/APHIS/VS/CEAH/NAHMS.
\25\ United States Department of Agriculture. Animal and Plant
Health Inspection Service. National Animal Health Monitoring System.
(October 2007). Swine 2006--part 1: reference of swine health and
management practices in the United States, 2006. (#N475.1007). Fort
Collins, CO:USDA/APHIS/VS/CEAH/NAHMS.
\26\ Antimicrobial Resistance--Implications for the Food System,
Institute of Food Technologists Expert Report, Comprehensive Reviews in
Food Science and Food Safety, Vol. 5, 2006 (Available at http://
members.ift.org/IFT/Research/IFTExpertReports/
antimicrobial_report.htm).
\27\ CDC. National Antimicrobial Resistance Monitoring System:
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
\28\ CDC. FoodNet. Facts and Figures related to ``Preliminary
FoodNet Data on the Incidence of Infection with Pathogens Transmitted
Commonly Through Food--10 States, United States, 2007'' published in
the Morbidity and Mortality Weekly Report (MMWR) on April 11, 2008.
(Available at http://www.cdc.gov/foodnet/factsandfigures.htm).
\29\ United States Department of Agriculture, Animal and Plant
Health Inspection Service. (June 2008). Veterinary biological products:
Licenses and Permittees. Ames IA: Center for Veterinary Biologics.
\30\ United States Department of Agriculture, Animal and Plant
Health Inspection Service , Animal Health. (June 2008) (Available at:
http://www.aphis.usda.gov/animal_health/).
\31\ United States Department of Agriculture. Cooperative State
Research, Education, and Extension Service. (no date). General
information on FARAD: FARAD and food quality. (Available at: http://
www.farad.org/gen.html#food).
\32\ Singer R.S. Modeling the Relationship between Food Animal
Health and Human Foodborne Illness. Prev. Vet. Med. 2007; 79: 186-203.
\33\ Russell S.M. The effect of airsacculitis on bird weights,
uniformity, fecal contamination, processing errors, and populations of
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
\34\ Russell S.M. Ban Antibiotics In Poultry? [Why The Policymakers
Have It Wrong], WATT Poultry/USA, March 2003.
\35\ Dawe J. The Relationship between Poultry Health and Food
Safety. Poultry Informed Professional 2004; 77:1-6.
\36\ Cox L.A., Ricci P. Causal regulations vs. political will: Why
human zoonotic infections increase despite precautionary bans on animal
antibiotics. Environ. Int. 2008 (in press).
\37\ Cox L.A., Popken D.A. Quantifying Potential Human Health
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in
Chickens. Risk Analysis 2006; 26:135-146.
\38\ Cox L.A. Potential human health benefits of antibiotics used
in food animals: a case study of virginiamycin. Environ. Int. 2005;
31:549-63.
\39\ Hurd S. et al. Potential Human Health Implications of Swine
Health, Abstract of Oral Presentation, 2007.
\40\ Hurd S. et al. Public Health Consequences of Macrolide Use in
Food Animals: A Deterministic Risk Assessment. J. Food Protection 2004;
67:980-992.
\41\ Cox L.A. Potential human health benefits of antibiotics used
in food animals: a case study of virginiamycin. Environ. Int. 2005;
31:549-63.
\42\ Cox L.A., Popken D.A. Quantifying Potential Human Health
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in
Chickens. Risk Analysis 2006; 26:135-146.
\43\ Cox L.A. et al. Human Health Risk Assessment of Penicillin/
Aminopenicillin Resistance in Enterococci Due to Penicillin Use in Food
Animals. 2008. In Press.
\44\ Alban, L. et al. A human health risk assessment for macrolide-
resistant Campylobacter associated with the use of macrolides in Danish
pig production. Prev. Vet. Med. 2008; 83:115-129.
\45\ Phillips I. et al. Does the use of antibiotics in food animals
pose a risk to human health? A critical review of published data. J. of
Antimicrobial Chemotherapy 2004: Vol. 53, pp. 28-52.
\46\ Cox LA. et al. Quantifying Human Health Risks from Animal
Antimicrobials. Interfaces. 2007; 37:22-38.
\47\ Antimicrobial Resistance--Implications for the Food System,
Institute of Food Technologists Expert Report, Comprehensive Reviews in
Food Science and Food Safety, Vol. 5, 2006 (Available at http://
members.ift.org/IFT/Research/IFTExpertReports/
antimicrobial_report.htm).
\48\ Heuer O.E. et al. Prevalence and antimicrobial susceptibility
of thermophilic Campylobacter in organic and conventional broiler
flocks. Letters in Applied Microbiology 2001; 33: 269-274.
\49\ Bailey J.S., Cosby D.E.. Salmonella Prevalence in Free-Range
and Certified Organic Chickens. J. of Food Protection 2005; 68:2451-
2453.
\50\ Wondwossen A. Gebreyes, Peter B. Bahnson, Julie A. Funk, James
McKean, Prapas Patchanee. Seroprevalence of Trichinella, Toxoplasma,
and Salmonella in Antimicrobial-Free and Conventional Swine Production
Facilities. Foodborne Pathogens and Disease. April 1, 2008, 5(2): 199-
203.
\51\ M. Bennish and W. Khan. Therapy Guidelines for Enteric
Infections--A 12-Year Update. 2007. In APUA Newsletter, Vol. 25, No. 3,
pp. 1-4.
\52\ CDC. National Antimicrobial Resistance Monitoring System:
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
\53\ Cox L.A., Ricci P. Causal regulations vs. political will: Why
human zoonotic infections increase despite precautionary bans on animal
antibiotics. Environ. Int. 2008 (in press)
The Chairman. Thank you.
Dr. Singer.
STATEMENT OF RANDALL S. SINGER, D.V.M., M.P.V.M, Ph.D.,
ASSOCIATE PROFESSOR OF EPIDEMIOLOGY, DEPARTMENT OF VETERINARY
AND BIOMEDICAL SCIENCES, COLLEGE OF VETERINARY MEDICINE, AND
DIVISION OF
ENVIRONMENTAL HEALTH, SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF
MINNESOTA, ST. PAUL, MN
Dr. Singer. Mr. Chairman, Members of the Subcommittee, I
would like to thank you for giving me the opportunity to
discuss the role of antibiotics in animal agriculture. My name
is Randall Singer. I am Associate Professor of infectious
disease epidemiology at the University of Minnesota, both in
the College of Veterinary Medicine and in the School of Public
Health. I received both my veterinary degree and my Ph.D. in
Epidemiology from the University of California at Davis.
To begin, let me restate the issue as I see it. What we are
really discussing is risk, and specifically, the potential that
the use of antibiotics in animal agriculture might result in
more antibiotic-resistant bacteria that can subsequently infect
humans and that then lead to either treatment failures or
prolonged illness due to that resistance. Given this
definition, I want to focus on two points. First, how should we
assess and manage these potential risks, and second, are there
actually any benefits to human health associated with the use
of antibiotics in animals?
So how do we assess and manage these potential risks to
human health? One approach is to employ the precautionary
principle, which states that if there is a perceived potential
for serious negative consequences, it is deemed better to avoid
an action entirely rather than to suffer the potential
consequences. The precautionary principle approach to managing
antibiotic use in animal agriculture has only one real option:
ban the antibiotic. But a more objective way to assess and
manage the risks of animal antibiotic use is to develop
scientifically based predictions using methods such as risk
assessment. The FDA Center for Veterinary Medicine uses a
science-based approach to decision-making, and in 1999 assessed
the human health risk of an antibiotic in chickens. Based on
the risk assessment model, FDA withdrew a very important
antibiotic to poultry veterinarians. Now, even though this
decision was science-based, I still had a major concern with
the model. It did not evaluate any intervention strategies for
reducing the risk to human health. Withdrawing the antibiotic
was the only option. For risk assessments to be useful, they
should evaluate strategies for reducing risk. Many potential
interventions could have been explored in the FDA model such as
processing chickens from treated and untreated flocks
separately or cooking the chicken meat from treated flocks
prior to distribution.
This leads to my final point. Let me ask a rhetorical
question. Let us say we start banning various antibiotics used
in animal agriculture, either because of the precautionary
principle or because our models do not evaluate risk reduction
strategies. Will there be any unintended consequences from
these actions? Stated another way, are there any potential
benefits to human health associated with antibiotic use in
animals? We have already heard about the animal health
benefits. Research shows that animals that have experienced
illness can lead to a meat product that has higher levels of
harmful bacteria on it including Salmonella and Campylobacter.
So healthier animals lead to a healthier food supply and
therefore healthier people. Antibiotics improve animal health
which under this argument leads to improved food safety and
improved human health.
Recently I was part of a team that developed a mathematical
model that related animal health to human health and,
simultaneously, evaluated the human health risks and benefits
associated with the use of antibiotics in animal agriculture.
The model showed that under certain circumstances, the
potential benefits to human health of antibiotic use in animals
far outweigh the potential risks.
So in conclusion, Mr. Chairman, Members of the
Subcommittee, I thank you again for the opportunity to speak
today. Antibiotics are an integral component of animal health.
All responsible uses of antibiotics improve animal health and
these improvements can substantially improve human health. All
uses of antibiotics also pose a risk mainly associated with
increases in antibiotic resistance. Simply removing antibiotics
from use in animal agriculture may help reduce some of the
antibiotic resistance circulating today but it might also have
severe unintended consequences. The key is to identify
strategies that maximize the benefits and minimize the risks.
The best way to manage antibiotic uses in animal agriculture is
through sound, rational, science-based policy. Thank you.
[The prepared statement of Dr. Singer follows:]
Prepared Statement of Randall S. Singer, D.V.M., M.P.V.M, Ph.D.,
Associate Professor of Epidemiology, Department of Veterinary and
Biomedical Sciences, College of Veterinary Medicine, and Division of
Environmental Health, School of Public Health, University of Minnesota,
St. Paul, MN
Mr. Chairman and Members of the Subcommittee:
Thank you for providing me with the opportunity to discuss the role
of antibiotics in animal agriculture and the potential risks and
benefits to animal and public health associated with these antibiotic
uses. I am an Associate Professor of Infectious Disease Epidemiology
and Ecology at the University of Minnesota. I have a dual appointment
at the university, both in the College of Veterinary Medicine and the
School of Public Health. I am a veterinarian by training with a degree
from the University of California at Davis. Following my veterinary
degree, I obtained a Ph.D. in epidemiology from the University of
California at Davis. I have worked as a professor of epidemiology since
1999, first at the University of Illinois, Urbana-Champaign and now at
the University of Minnesota. I have spent the past 10 years engaged in
research, teaching and service activities related to antibiotic use and
antibiotic resistance in human and animal health. I will focus my
discussion on four questions that I think are critically important:
1. What are antibiotics and how are they used in animal
agriculture?
2. What is antibiotic resistance and how is it selected?
3. How do we assess and manage the risks of antibiotic use in
animal agriculture?
4. Are there benefits to antibiotic use in animal agriculture?
What are antibiotics and how are they used in animal agriculture?
Although many people assume that antibiotics are human-made
compounds, antibiotics are actually small molecules that are naturally
produced by microorganisms in the environment. Humans have created
synthetic analogs to these naturally occurring compounds to improve
their efficacy. The function of these molecules in nature is still not
entirely understood. Because bacteria in the environment have been
exposed to these antibiotics for eons, they have developed mechanisms
for survival in the presence of these compounds. These mechanisms are
what we refer to as antibiotic resistance, or a way for the bacterium
to resist the action of the antibiotic. The presence of naturally
produced antibiotics in the environment is rarely considered as a
contributor to the amount of resistance that is found in bacteria
around the world, and yet it is this environmental pool of resistance,
lately termed the resistome [5], that is the basis for the resistance
observed today. Antibiotic resistant microorganisms can be found in
areas with little to no obvious human influence or impact, emphasizing
that there is a large background reservoir of resistance that exists in
the natural world.
Antibiotics are used in animal agriculture in four major ways:
disease treatment, disease control, disease prevention, and growth
promotion. Briefly, disease treatment refers to the use of the
antibiotic in an ill animal. Disease control refers to the use of the
antibiotic in a population of animals during a time of illness. Not all
of the animals receiving the antibiotic are necessarily ill at the time
of antibiotic administration. Disease prevention refers to the use of
the antibiotic in an animal or in a population of animals at a time
when it is known that the animals are susceptible to disease. Finally,
growth promotion refers to the use of the antibiotic in a low-dose
fashion to improve the weight gain and feed efficiency of the animal.
All four of these uses result in an improved health of the animal
receiving the antibiotic, and as will be discussed later, can thereby
improve the safety of the food supply.
Even though all four of these uses can improve the health of the
animal, there has still been confusion about them. One area of
confusion is related to the amount of antibiotic that is administered.
Because disease control, disease prevention and growth promotion can
use smaller amounts of the antibiotic than is given to the sick animal
during disease treatment, these uses have sometimes been labeled as
``subtherapeutic'' or ``nontherapeutic''. Given that animals receiving
an antibiotic in this manner are healthier than if they had not
received the antibiotic, these terms are misnomers. Another area of
confusion is related to the route of administration. Uses of
antibiotics that are ``in-feed'' are often equated with growth
promotion uses and are assumed to be long-term low-dose regimens of
antibiotic administration for the sole purpose of improving weight
gain. In fact, all of these uses can be applied via the feed or the
water because the only realistic way to give antibiotic to populations
of animals, such as a flock of chickens, is through the feed or the
water. Antibiotics used for disease treatment and disease control are
often given via the drinking water because sick animals may stop eating
but often continue to consume water.
What is antibiotic resistance and how does it develop?
Antibiotic resistance refers to the ability of a microorganism to
survive the effects of an antibiotic. As stated previously, antibiotics
are naturally produced by environmental microorganisms, and as a
result, many microorganisms possess mechanisms that enable them to
resist the action of the antibiotic. Some microorganisms are
intrinsically resistant to the action of certain antibiotics, meaning
that the antibiotic has no function on the organism. This type of
resistance can not be spread and is not of concern when considering
antibiotic uses. Instead, we are typically concerned about antibiotic
resistance that is acquired by the microorganism. The two major
mechanisms by which the microorganism can acquire resistance are
through random changes in the genetic makeup, known as mutation, or
through the sharing of genetic material with other microorganisms.
When an antibiotic is applied to a population of bacteria, those
bacteria that are not intrinsically resistant to its action must find a
way to survive. The antibiotic will either kill or suppress the
bacteria that are susceptible to the antibiotic. For this reason, the
antibiotic is said to select for resistant bacteria because only the
resistant ones can withstand the pressure imposed by the antibiotic.
During the course of the antibiotic, the rates at which bacteria can
acquire resistance might increase, and consequently, the use of the
antibiotic may pose a risk to human and animal health through the
selection of a more resistant bacterial population. The problem, stated
simply, is how do we ensure that the human and animal health benefits
of antibiotic use in animal agriculture outweigh the risks?
How do we assess and manage the risks of antibiotic use?
There are two primary approaches for assessing and managing the
potential risks associated with antibiotic use in animal agriculture.
One approach is to employ the precautionary principle. In this
argument, the precise public health risks associated with animal
antibiotic use might not be known. Because there is a perceived
potential for serious negative consequences, it is deemed better to
avoid the action entirely rather than to suffer the potential
consequences. Europe has used this principle to withdraw certain
antibiotic uses from animal agriculture [1]. One reason why this
approach is often relied upon, especially in the case of antibiotic use
and resistance, is the belief that antibiotic use is negatively
impacting human health. It is extremely difficult to design, implement
and analyze the decisive study that will prove or disprove this theory.
Caution would dictate that by the time such a study is complete, any
negative effects associated with continued antibiotic use might be
irreversible. Consequently, the precautionary principle approach to
managing antibiotic use in animal agriculture has only one real option:
withdraw the antibiotic use that might result in a negative human
health consequence. Unfortunately, there can be negative unintended
consequences associated with a precautionary measure [4] as will be
discussed later.
A more objective way to evaluate the potential consequences of
antibiotic use in livestock and poultry is to develop scientifically-
based predictions, and through these models, evaluate interventions
that reduce potential human and animal health risks associated with
certain antibiotic uses in animal agriculture. This approach includes
the methodology known as risk assessment. For example, in 2003 the FDA
Center for Veterinary Medicine (FDA-CVM), which uses a scientific
approach to regulatory decisions, issued a Guidance for Industry
document #152 that described a qualitative risk assessment process that
is utilized in the approval of all applications for new animal
antibiotics and the reassessment of existing animal antibiotics. I was
recently part of a team that conducted a risk assessment following the
document #152 approach. Specifically, we assessed the risk that the
agricultural use of a family of antibiotics known as macrolide
antibiotics poses to human health [7]. The concern is that macrolide
antibiotics are also used in human medicine, and therefore, the use of
macrolide antibiotics in animal agriculture could compromise the
efficacy of these antibiotics in human medicine and potentially
increase the number of macrolide-resistant bacterial infections in
people. We developed a semi-quantitative risk assessment model
following the format of document #152. We found that all macrolide
antibiotic uses in animal agriculture in the U.S. posed a very low risk
to human health. The highest risk was associated with macrolide-
resistant Campylobacter infections acquired from poultry, but this risk
was still estimated to be less than 1 in 10 million and would thus meet
the standard of ``reasonable certainty of no harm'' employed by FDA-
CVM.
Currently, the international body Codex Alimentarius has formed a
Task Force to delineate international standards for the conduct of risk
assessment and risk management in the context of antibiotic use in
animal agriculture. The main purposes of the Codex Alimentarius are
``protecting health of the consumers and ensuring fair trade practices
in the food trade, and promoting coordination of all food standards
work undertaken by international governmental and non-governmental
organizations.'' Once this Task Force has completed its objective,
there will be a set of accepted, scientifically-based approaches for
determining if antibiotic uses in animal agriculture pose a risk to
human health, and if so, how these risks should be managed. Perhaps
most important, the final document of this Task Force will outline
procedures for assessing whether interventions that are used to
mitigate risk have succeeded or whether they have been counter-
productive.
Unfortunately, most risk assessments conducted to date in
antibiotic resistance that have been used for regulatory purposes have
not included specific interventions that can be implemented to reduce
the human and animal health risks. Instead, the assessments seem to
have been designed for the sole purpose of making the dichotomous
decision of whether or not to withdraw an antibiotic from use. For risk
assessments to be useful, they must include evaluations of potential
interventions for reducing the risks to human and animal health. In the
U.S. FDA-CVM risk assessment of fluoroquinolone use in chickens [2],
the model only estimated the potential human health impact of this
antibiotic use and did not evaluate ways for minimizing the risk
associated with fluoroquinolone use in poultry. For example, the model
could have examined the possibility of processing chickens from treated
poultry flocks separately from chickens from untreated flocks as a
potential risk reduction strategy. This separated processing could help
reduce the chance of cross-contamination of chicken meat from non-
treated poultry flocks with the bacteria from treated flocks. The model
could have examined a potential intervention in which farms that have
received fluoroquinolones are cleaned in a more intensive manner than
the normal cleaning, and all litter from these flocks is sterilized.
Finally, the model could have assessed an intervention in which flocks
that have been treated with antibiotics would have to wait for a longer
period of time before processing. This type of approach would resemble
the mandatory withdrawal times associated with antibiotic residues.
Guidelines could then be developed to determine when specific
antibiotic uses should be ceased in flocks before they go to processing
in order to reduce the amount of antibiotic resistant bacteria in the
birds. Consideration of such risk mitigation interventions rather than
complete withdrawal of these drugs would have been very important to
poultry veterinarians. Prescription drugs like the fluoroquinolones are
a valuable option to control fatal respiratory disease in chickens
since other effective therapeutic alternatives are not available.
These types of interventions might sound labor-intensive and
costly. They are, and that is the point. Under certain circumstances,
it might be cost-effective and ethical for a veterinarian to use a
powerful antibiotic to control a severe disease in the herd or flock,
but this use would then have major repercussions on how the herd or
flock as well as the farm are subsequently managed. Producers might not
opt for this intensive measure, but at least they would have a choice
that is accepted as scientifically-sound for reducing both the human
and animal health risks associated with the antibiotic use on their
farm. As we begin to gain a better understanding of the ecology of
resistance and its relation to animal and human health, we will need
these scientifically-based strategies for minimizing the impacts of
antibiotic use on animal, human and environmental health.
Are there benefits to antibiotic use in animals?
The models that we build to assess the potential risks of
antibiotic use in livestock and poultry must begin to take a more
holistic view of health into consideration. Specifically, these models
need to include the potential risks and the potential benefits
associated with antibiotic use. Phrased another way, are there
potential unintended consequences of removing antibiotics from use in
food animals? Recent models have predicted that there might be
significant negative human health consequences associated with the
removal of certain antibiotics from animal production. This is an
instance in which the precautionary principle would lead to an action
of banning antibiotics in animal agriculture, but that action could
have even worse unintended consequences. It might not be intuitive,
however, how an antibiotic that is used in animal agriculture can
actually benefit human health.
The health status of animals that are processed for meat can
potentially affect food safety in two major ways. First, animals that
are less healthy may shed higher levels of harmful bacteria, such as
Salmonella and Campylobacter. Second, groups of animals that have
experienced illness, either clinically or subclinically, can be smaller
in size and more variable in size. During processing, these factors can
contribute to an increased likelihood of the gastrointestinal tract
being ruptured, and this processing error can lead to increased
contamination and cross-contamination of the meat and thus increase the
risk of human foodborne illness. Reducing animal illness likely plays a
critical role in reducing the chances of contamination during
processing.
I recently was part of a team that developed a mathematical model
that relates animal illness to human illness [8]. In our model, there
was a large increase in human illness associated with small increases
in animal illness, suggesting that agricultural management strategies
may have significant impacts on human health. Antibiotics administered
in feed at low doses over several weeks raise concern about their
potential to increase rates of antibiotic resistance, posing a risk to
human health. However, these applications also improve animal health
and promote size uniformity among animals in the herd or flock.
Antibiotic uses in animals can therefore have potential human health
risks and benefits. Our model was able to evaluate simultaneously the
human health risks and benefits associated with antibiotic use in
animal agriculture. Specifically, the model addressed the relationship
between the negative human health impact of increased antibiotic
resistance and the positive human health impact of fewer foodborne
infections, both of which are due to the use of the antibiotic in
animal agriculture. The model showed that the potential benefits to
human health associated with the use of antibiotics in animal
agriculture can far outweigh the potential risks. This finding has now
been validated by additional studies [3] [6].
In summary, Mr. Chairman and Members of the Subcommittee, thank you
again for the opportunity to discuss the role of antibiotics in animal
agriculture. Antibiotics are an integral component of animal health.
All uses of antibiotics improve animal health, and these improvements
in animal health can substantially improve human health. All uses of
antibiotics also pose a risk, mainly associated with increases in
antibiotic resistance. The key is to assess the ability of
interventions to maximize the benefits and minimize the risks
associated with the agricultural use of antibiotics. Simply removing
antibiotics from use in animal agriculture may help reduce some of the
antibiotic resistance circulating today, but it might also have severe
unintended consequences. The best way to manage antibiotic uses in
animal agriculture is through sound, rational, science-based policy.
References
[1] Aarestrup, F.M., A.M. Seyfarth, H.D. Emborg, K. Pedersen, R.S.
Hendriksen, and F. Bager. 2001. Effect of abolishment of the use of
antimicrobial agents for growth promotion on occurrence of
antimicrobial resistance in fecal Enterococci from food animals in
Denmark. Antimicrob. Agents Chemother. 45:2054-2059.
[2] Bartholomew, M.J., D.J. Vose, L.R. Tollefson, and C.C. Travis.
2005. A linear model for managing the risk of antimicrobial resistance
originating in food animals. Risk Anal. 25:99-108.
[3] Berrang, M.E., S.R. Ladely, R.J. Meinersmann, and P.J. Fedorka-
Cray. 2007. Subtherapeutic tylosin phosphate in broiler feed affects
Campylobacter on carcasses during processing. Poult. Sci. 86:1229-1233.
[4] Cox, L.A., Jr., P.F. Ricci. 2008. Causal regulations vs.
political will: why human zoonotic infections increase despite
precautionary bans on animal antibiotics. Environ. Int. 34:459-475.
[5] D'Costa, V.M., K.M. McGrann, D.W. Hughes, and G.D. Wright.
2006. Sampling the antibiotic resistome. Science 311:374-377.
[6] Hurd, H.S., S. Malladi. 2008. A stochastic assessment of the
public health risks of the use of macrolide antibiotics in food
animals. Risk Anal. 28:695-710.
[7] Hurd, H.S., S. Doores, D. Hayes, A. Mathew, J. Maurer, P.
Silley, R.S. Singer, and R.N. Jones. 2004. Public health consequences
of macrolide use in food animals: a deterministic risk assessment. J.
Food Prot. 67:980-992.
[8] Singer, R.S., L.A. Cox Jr., J.S. Dickson, H.S. Hurd, I.
Phillips, and G.Y. Miller. 2007. Modeling the relationship between food
animal health and human foodborne illness. Prev. Vet. Med. 79:186-203.
The Chairman. Well, thank you very much. You may have heard
us pose this question to an earlier group. Give us some idea of
what goes into developing an antibiotic in time, cost to bring
it to market. Can you give us some feeling for what is involved
in all that?
Dr. Carnevale. Yes, thank you, Mr. Chairman, for that
question. It is a very rigorous process. I think Dr. Dunham
explained that the drug has to be shown to be safe and
effective to the animal as well as manufactured properly. There
is an environmental impact component. Clearly, the human food
safety from residues and antibiotics presents a significant
amount of research. We have estimated at the Animal Health
Institute that for a food-producing animal, it can take 7 to 10
years to develop a product from essentially discovery to final
approval, and it costs upwards of $100 million. However, there
are some examples of products that have actually cost more than
that and taken many more years than 7 to 10 years. But that
would be an average. So it is a fairly rigorous time and costly
process to get a new animal drug through the process and that
would include antibiotics. Antibiotics have a particularly
difficult time getting through the system today because of this
resistance issue. FDA takes a lot of time and care and data
requirements to prove that these antibiotics aren't dangerous
to human health, so that adds another several years and
probably several million more dollars to the development of
those. It is very, very difficult to get a new compound on the
market today because of that.
The Chairman. Thank you very much. Anybody else?
Mr. Hayes.
Mr. Hayes. Again, very thorough. My only question would be
from your perspective as scientists and doctors, is there
anything that FDA or anyone in the community that is monitoring
what you all are doing, any other testing from your perspective
that could be done that would fill in any blank that I haven't
seen today, but that in somebody's mind might exist?
Dr. Hoang. Currently the only system that we have for
monitoring outbreaks of foodborne illness is FoodNet, and that
is the only system that has both a component that monitors the
bacteria as well as the epidemiological study behind it. NARMS
is a separate system that monitors antimicrobial resistance.
However, there really is no link between those two systems to
accurately indicate the incidence of foodborne illness of
resistant pathogens in humans, and also have it be traced back
to consumption of animal products. Thank you, sir.
Mr. Hayes. I guess another thing, and as far as domestic is
concerned, the evidence that all of you presented is, in my
opinion, irrefutable. But, Mr. Chairman, as you know, we
continue to run into artificial trade barriers based around
some of these issues too. So, I guess my question was directed
at that part of our agricultural economy as well. Any other
comments from Dr. Carnevale, Dr. Singer?
Dr. Singer. In relation to the global food system, I mean,
this is part of what the Codex Alimentarius, the task force on
antimicrobial resistance, is currently working on. How do we
come up with international standards for looking at risks, for
conducting risk assessments, and most importantly, for
implementing risk management strategies. How do nations and
regions interact in this case, and so that pilot process is
underway. It is a 4 year process, the specific task force.
Mr. Hayes. I have no further questions, Mr. Chairman. Thank
you.
The Chairman. Thank you, Mr. Hayes. Because of your
expertise and background, I wonder if any or all of you would
care to make a comment about your analysis of the situation
that happened in Denmark and the impact. What would be your
analysis of that whole thing that happened there?
Dr. Hoang. Based upon our analysis of the experience in
Denmark, we found that there has been no significant human
health benefit as a result of that ban. However, we have seen
that there has been a decrease in animal welfare and animal
health and the increase of therapeutic use of antimicrobials.
Unfortunately, some of the therapeutic antimicrobials are in
the same classes as human medications, which poses more of a
risk to human health. Thank you, sir.
Dr. Carnevale. Yes, I would certainly support what
Christine said. I think the situation in Denmark was a clear
example of the government wanting to take an action based on
the idea that there was a perceived risk to human health. What
they found is that there was a greater risk to animal health by
their action. It was very interesting to me that a couple of
years after that Denmark ban on growth promoters, a Danish
official at a meeting here in the United States actually
admitted that they did not realize that these growth-promoting
antibiotics added to feed were suppressing disease. They
thought they were strictly promoting growth, but in fact they
found out when they took them out of feed that they had a lot
of nursery pig diarrhea and a significant number of nursery pig
deaths in the first several years of that program. So I think
that that program has been, although they would not admit it, a
real failure because it simply increased cost to their pork
industry. And as Christine said, there has been no indication
that it has improved human health at all.
The Chairman. Dr. Singer?
Dr. Singer. While we don't have the perfect example here in
the United States, we can use organic meat production and
antibiotic-free meat production here in the United States for
some indication of what we might expect. Research studies do
show that the antibiotic-free and organic meat production, the
meat produced in those systems can have higher levels of
pathogenic bacteria such as Salmonella and Campylobacter on it
than conventionally reared meat. It also might have less
antibiotic resistance. So the key here again is a risk-benefit
type of analysis. It is not good enough for us to say that the
resistance is the only issue we should be considering. We need
to weigh both the risks and the benefits.
The Chairman. Thank you very much.
Mr. Hayes, do you have any closing remarks?
Mr. Hayes. I appreciate the participation of the witnesses
and the willingness of the Chairman and the staff to put this
together. I think it is very positive.
The Chairman. I think it has been very productive today. It
has certainly been an educational process. Just since we have
been here this morning, Mr. Hayes, I have gotten word that even
with the statements made by our first panel, and then the
concerns by the second panel that the FARAD program that you
and I wrote a letter about is not a priority at USDA, so we may
have to pursue that a little more. So I think that probably
could be the reason why we haven't received a response to our
July letter.
But anyway, I want to thank everyone who has joined us
today. I hope everyone found the testimony as informative as I
have. We have had the opportunity to hear from our regulatory
agencies, actual producers on the ground and numerous
veterinarians and researchers. I hope we leave here today with
resolve to continue to move forward and ensure that consumers
in the United States have the safest, most plentiful and most
affordable food supply in the world. I believe that is the case
because of the work that has gone into it. It is clear from
today's hearing that antimicrobials play an extremely important
role in producing healthy animals and even a healthier food
supply.
With that, under the rules of the Committee, the record of
today's hearing will remain open for 10 days to receive
additional material and supplementary written responses from
witnesses to any question posed by a Member of the panel.
This hearing of the Subcommittee of Livestock, Dairy, and
Poultry is adjourned. Thank you.
[Whereupon, at 12:20 p.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Submitted Statement of Hon. Louise M. Slaughter, a Representative in
Congress from New York
Thank you Chairman Boswell and Ranking Member Hayes for allowing me
to submit testimony on this important public health topic. With
antibiotic resistance growing at an alarming rate, it is becoming
harder and more expensive to treat common bacterial infections. The
problem has become so significant that it has been labeled a ``top
concern'' by the Centers for Disease Control and Prevention (CDC), and
the World Health Organization has called it a ``crisis.'' Therefore, it
is critically important that we act now to protect our current stocks
of antibiotics.
Two million Americans acquire bacterial infections during their
hospital stay every year, and 70 percent of their infections will be
resistant to the drugs commonly used to treat them. As a result, every
day 38 patients in our hospitals will die of those infections.
Sadly, children and infants are particularly susceptible to
infections caused by antibiotic resistant bacteria. For example,
Salmonella causes 1.4 million illnesses every year. Over \1/3\ of all
diagnoses occur in children under the age of 10. Infants under the age
of one are ten times more likely than the general population to acquire
a Salmonella infection. In 1995, 19 percent of Salmonella strains were
found to be multi-drug resistant. That means that our children are left
to undergo multiple treatments for otherwise simple infections because
we have allowed traditional treatments to become ineffective.
And the cost to our already strained health care system is
astronomical. In fact, resistant bacterial infections increase health
care costs by $4 billion to $5 billion each year.
We cannot in good conscience stand by while our life-saving
antibiotics become obsolete. While overuse of antibiotics among humans
is certainly a major cause for increasing resistance, there is evidence
that the widespread nontherapeutic use of antibiotics in animal feed is
another cause of heightened resistance. A National Academy of Sciences
report states that, ``a decrease in antimicrobial use in human medicine
alone will have little effect on the current situation. Substantial
efforts must be made to decrease inappropriate overuse in animals and
agriculture as well.''
Currently, seven classes of antibiotics certified by the Food and
Drug Administration (FDA) as ``highly'' or ``critically'' important in
human medicine are used in agriculture as animal feed additives. Among
them are penicillin, tetracyclines, macrolides, lincosamides,
streptogramins, aminoglycosides, and sulfonamides. These classes of
antibiotics are among the most critically important in our arsenal of
defense against potentially fatal human diseases.
Penincillins, for example, are used to treat infections ranging
from strep throat to meningitis. Macrolides and Sulfonamides are used
to prevent secondary infections in patients with AIDS and to treat
pneumonia in HIV-infected patients. Tetracyclines are used to treat to
people potentially exposed to anthrax.
Despite their importance in human medicine, these drugs are added
to animal feed as growth promotants and for routine disease prevention.
Approximately 70 percent of antibiotics and related drugs produced in
the U.S. are given to cattle, pigs, and chicken to promote growth and
to compensate for crowded, unsanitary, stressful conditions. The
nontherapeutic use of antibiotics in poultry skyrocketed from 2 million
pounds in 1985 to 10.5 million pounds in the late 1990s.
This kind of habitual, nontherapuetic use of antibiotics has been
conclusively linked to a growing number of incidents of antimicrobial-
resistant infections in humans, and may be contaminating ground water
with resistant bacteria in rural areas.
Resistant bacteria can be transferred from animals to humans in
several ways. Antibiotic resistant bacteria can be found in the meat
and poultry that we purchase in the grocery store. In fact, a New
England Journal of Medicine study conducted in Washington, D.C. found
that 20 percent of the meat sampled was contaminated with Salmonella
and 84 percent of those bacteria were resistant to antibiotics used in
human medicine and animal agriculture. Bacteria can also be transferred
from animals to humans via workers in the livestock industry who handle
animals, feed, and manure. Farmers may then transfer the bacteria on to
their family. A third method is via the environment. Nearly 2 trillion
pounds of manure generated in the U.S. annually contaminate our
groundwater, surface water, and soil. Because this manure contains
resistant bacteria, the resistant bacteria can then be passed on to
humans that come in contact with the water sources or soil.
And the problem has been well documented.
A 2002 analysis of more than 500 scientific articles and published
in the journal Clinical Infectious Diseases found that ``many lines of
evidence link antimicrobial resistant human infections to foodborne
pathogens of animal origin.''
The Institute of Medicine's 2003 report on Microbial Threats to
Health concluded ``Clearly, a decrease in the inappropriate use of
antimicrobials in human medicine alone is not enough. Substantial
efforts must be made to decrease inappropriate overuse in animals and
agriculture as well.''
As recently as last November, in FDA Week, the article below
entitled ``Study Fuels Call for FDA to Phase Out Antibiotics In Animal
Feed'' highlighted how methicillin-resistant Staphylococcus aureus
(MRSA) is prevalent in Canadian pig farms and pig farmers.
Study Fuels Call for FDA To Phase Out Antibiotics in Animal Feed
9 November 2007
FDA Week
Vol. 13, No. 45
A new study has found that methicillin-resistant Staphylococcus
aureus (MRSA) is prevalent in Canadian pig farms and pig
farmers, pointing to animals as a source of the deadly bacteria
and raising new questions about the use of human antibiotics in
animal feed. Health advocates are using the study's results to
drum up support for the Preservation of Antibiotics for Medical
Treatment Act, which would phase out the use of antibiotics
important in human medicine as animal feed additives within 2
years.
The Veterinary Microbiology study (Khanna et al. 2007) is the
first to show that North American pig farms and farmers have
carried MRSA. The study looked for MRSA in 285 pigs in 20
Ontario farms. It found MRSA at 45 percent of farms (9 of 20)
and in nearly one in four pigs (71 of 285). One in five pig
farmers studied (5 of 25) also were found to carry MRSA, a much
higher rate than in the general North American population,
according to the study. The strains of MRSA bacteria found in
Ontario pigs and pig farmers included a strain common to human
MRSA infections in Canada.
The study stated MRSA colonization in pigs was first reported in
the Netherlands and has also been found in pigs in France,
Denmark, and Singapore. In all of these countries, farm and pig
workers were found to have been infected with MRSA by pigs.
The study was published in October.
Also in October, the Journal of the American Medical Association
(Klevens et al. 2007) published a study that estimated almost
100,000 MRSA infections in 2005, and nearly 19,000 deaths in
the United States. In comparison, HIV/AIDS killed 17,000 people
that year, according to the study.
A pending bill, The Preservation of Antibiotics for Medical
Treatment Act, would phase out the use of antibiotics as animal
feed additives within 2 years. The Senate version of the
legislation is sponsored by Health Committee Chair Edward
Kennedy (D-MA) and Sens. Olympia Snowe (R-ME), Susan Collins
(R-ME), Sherrod Brown (D-OH) and Jack Reed (D-RI). The House
version is sponsored by Rep. Louise Slaughter (D-NY), the only
microbiologist in Congress, and 34 other House Members.
The American Medical Association, the Infectious Diseases Society
of America and the American Academy of Pediatrics are among the
more than 350 advocacy groups nationwide that have endorsed
this bill.
Until recently, scientists believed MRSA was an infection
occurring mainly in hospitals. The JAMA study found that even
healthy people are developing MRSA infections. The Veterinary
Microbiology study points to pig farms as a possible source of
these resistant infections, as have earlier European studies.
A recent study in the Netherlands found MRSA transmission among
pigs, pig farmers and their families.
Members of the Keep Antibiotics Working coalition, including
medical, agriculture and environmental experts, are calling for
Congress to compel FDA to study whether the use of human
antibiotics in animal agriculture is contributing to the
reported surge in MRSA infections and deaths in the United
States.
``Identifying and controlling community sources of MRSA is a
public health priority of the first order,'' said Richard Wood,
Executive Director of Food Animal Concerns Trust and Steering
Committee Chair of Keep Antibiotics Working. ``Are livestock
farmers and farms in the United States also sources? We don't
know for sure, because the U.S. Government is not
systematically testing U.S. livestock for MRSA.''
``Last summer, when we raised the MRSA issue, the FDA told us
that it had no plans to sample U.S. livestock to see if they
carry MRSA,'' said David Wallinga, Director of the Institute
for Agriculture and Trade Policy's Food and Health Program.
``Given the latest science that hog farms may generate MRSA, we
need Congress to give FDA and other relevant agencies the
necessary funding and a sense of urgency. Sampling needs to be
done as soon as possible.''--Inside OSHA.
As the impact of MRSA continues to unfold, there is little doubt
that antibiotic resistant diseases are a growing public health menace
demanding a high priority response. Despite increased attention to the
issue, the response has been inadequate. Part of the problem has been
the FDA's failure to adequately address the effect of the misuse of
animal antibiotics on the efficacy of human drugs.
Although the FDA could withdraw its approval for these antibiotics,
its record of reviewing currently approved drugs under existing
procedures indicate that it would take nearly a century to get these
medically important antibiotics out of the feed given to food producing
animals. In October 2000, for example, the FDA began consideration of a
proposal to withdraw its approval for the therapeutic use of
fluoroquinolones in poultry. The review, and eventual withdraw of
approval, took 5 years to complete. Under its regulations, the FDA must
review each class of antibiotics separately.
In 2003, the Center for Veterinary Medicine at FDA released
Guidance 152 which provides safety guidelines on how antibiotics should
be used in agriculture. However, the guidance never established a
timeframe for FDA to reevaluate existing antibiotics used in animal
feed and so has rendered these recommendations useless.
During discussions involving the now-enacted farm bill, I supported
language which would have provided the farm industry with sound,
scientific information on production practices that could have helped
them reduce their dependence on antibiotics and meet the growing
consumer demand for meat produced without these drugs. The ability to
grow food animals with fewer antibiotics would have also given U.S.
exporters an advantage in the international marketplace. This language
would have also increased research on the movement of antibiotics and
antibiotic-resistant traits in water to aid public health professionals
in developing new tools and methods for reducing the spread of
resistant diseases. Disappointingly, however, industry successfully
lobbied to strip this language out of the farm bill.
I am also the sponsor of H.R. 962, the Preservation of Antibiotics
for Medical Treatment Act (PAMTA). This bill requires three actions to
accomplish the goal of reducing antibiotic resistance in humans. PAMTA
would phase out the use of the seven classes of medically significant
antibiotics that are currently approved for nontherapeutic use in
animal agriculture. Because the bill defines nontherapeutic use as ``in
the absence of any clinical sign of disease in the animal for growth
promotion, feed efficiency, weight gain, routine disease prevention, or
other routine purpose,'' this bill would in no way infringe upon the
use of these drugs to treat a sick animal.
In addition, PAMTA provides that if an antibiotic that is now used
only in animals also becomes potentially important in human medicine,
the drug would be automatically restricted from nontherapeutic use in
agricultural animals unless FDA determines that such use will not
contribute to development of resistance affecting humans.
Last, to assist public health officials in tracking implementation
of the phase out of antibiotics in animal feed, PAMTA requires
producers of agricultural antibiotics to report the quantity of drugs
they sell, information on the claimed purpose, and the dosage form of
those drugs.
The fundamental solution to the problem of antibiotic resistance is
to reduce unnecessary use. Then when antibiotics are required, use them
prudently. Most antibiotics in agriculture are used for growth
promotion and routine disease prevention--uses that can be reduced, if
not eliminated, in properly designed animal production systems. Drastic
reduction of antibiotics uses in animal agriculture, as called for in
PAMTA, will lessen the encouragement of resistant disease and prolong
the longevity of vital human drugs.
As a mother, grandmother, and microbiologist, I cannot stress the
urgency of this problem enough. When we go to the grocery store to pick
up dinner, we should be able to buy our food without worrying that
eating it will expose our family to potentially deadly bacteria that
will no longer respond to our medial treatments. Unless we act now, we
will unwittingly permit animals to serve as incubators for resistant
bacteria.
It is time for Congress to stand with scientists, the World Health
Organization, the American Medical Association, and the National
Academy of Sciences and do something to address the spread of resistant
bacteria. We cannot afford for our medicines to become obsolete.
Thank you.
______
Submitted Statement of Keep Antibiotics Working
Keep Antibiotics Working appreciates this opportunity to provide
the Committee information regarding the relation between antibiotics
use in livestock and the growing problem of antibiotic resistance--a
major health problem for both humans and animals. Keep Antibiotics
Working is a coalition of health, consumer, agricultural,
environmental, humane and other advocacy groups with more than ten
million members dedicated to eliminating a major cause of antibiotic
resistance: the inappropriate use of antibiotics in food animals.
Antibiotic Resistance: A Major Threat to Public Health
Antibiotic-resistant disease has been identified by the Centers for
Disease Control as one of the top public health challenges in the
United States.\1\ Resistant strains are often more virulent than their
susceptible counterparts, require longer hospital stays, result in more
time away from work, and cause dramatically increased human
suffering.\2\ Resistant diseases, which are on the upswing, are
increasingly costly to treat--by one estimate adding over $4 billion
per year to the health care tab in the U.S.\3\
---------------------------------------------------------------------------
\1\ Centers for Disease Control (CDC). 2004. Background on
antibiotic resistance. Online at http://www.cdc.gov/drugresistance/
community/, accessed on February 9, 2004.
\2\ Cosgrove S. 2006. The Relationship Between Antimicrobial
Resistance and Patient Outcomes: Mortality, Length of Hospital Stay,
and Health Care Costs. Clinical Infectious Diseases 2006 42:s2, S82-
S89. Online at http://www.journals.uchicago.edu/doi/abs/10.1086/499406.
\3\ National Academy of Sciences Institute of Medicine. 1998.
Antimicrobial Resistance: Issues and Options. Washington, D.C.:
National Academies Press, p. 1.
---------------------------------------------------------------------------
The rise of resistant of resistant bacterial diseases is the result
of over- and misuse of antibiotics in both human and animal medicine.
The crisis will not be alleviated by the arrival of new drugs. There
virtually no new drugs in the pipeline. Instead, the solution to the
crisis will require action in both human medicine and food animal
agriculture to reduce unnecessary and inappropriate use of our existing
arsenal. To date, the veterinary and industrial agriculture community
lags behind the human medical community in taking steps to respond to
this crisis. Instead it has spent its energies in minimizing or denying
the problem.
Antibiotic Resistance and Animal Agriculture
As the ``one health'' concept seeks to emphasize, it is unwise to
think of animal and human diseases separately. In fact, 60% of known
human diseases can be transmitted from animals to humans.\4\ In the
case of antibiotic resistance, the use of the same classes of
antibiotics in food animal production and human medicine creates
populations of antibiotic-resistant bacteria carried in or on food
animals.\5\ These microorganisms can readily travel back and forth
between humans and animals--on food, on workers handling livestock, or
through the environment. When resistant bacteria move off the farm, the
resistance goes with them.
---------------------------------------------------------------------------
\4\ Taylor L.H., Latham S.M., Woolhouse M.E.J. Risk Factors for
Human Disease Emergence. Philos. Trans. R. Soc. Lond. B. Biol. Sci.
Jul. 29, 2001. 356(1411):991-9.
\5\ McEwen, S., Fedorka-Cray P. 2002. Antimicrobial Use and
Resistance in Animals. CID 34 (Suppl. 3):S93-106. While many factors
influence the level of resistance in bacteria in farm animals, the most
important factor is the use of antimicrobial drugs (Catry et al.
Antimicrobial resistance in livestock. J. Vet. Pharmacol. Therap.
26:81-93, 2003.
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Currently, animal agriculture uses the lion's share of the
antibiotics in the United States--some 13 million pounds of antibiotics
every year, about 70 percent of total of all antibiotics used.\6\ The
majority of these antibiotics are not used for treating sick animals
but for purposes like growth promotion and prevention. These
antibiotics used in agriculture are the very same as those used in
human medicine--penicillin, tetracycline and erythromycin.
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\6\ Mellon M., Benbrook C., Benbrook K. 2000. Hogging it!:
Estimates of Antimicrobial Abuse in Livestock. Cambridge, MA: Union of
Concerned Scientists, p. 60. Online at http://www.ucsusa.org/food.
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As long as this massive use continues, animal agriculture will
remain a fountain of resistant organisms, dangerous to both animals and
humans. The straightforward solution to the problem is to reduce the
use of antibiotics in animal production and thereby the pool of
resistant organisms they generate.
The Erosion of the Efficacy of Human Use Drugs
A mountain of scientific studies over the last thirty years
documents that the overuse of antibiotics in animal agriculture
undercuts the efficacy of antibiotics. For example, the CDC has found
that half of all human Campylobacter infections are resistant as are
one in five Salmonella infections.\7\ These bacteria, which come from
livestock and poultry, are the two most common foodborne illnesses in
the U.S. from these two pathogens alone, there are well over a million
resistant infections in the U.S. each year. Resistance in Campylobacter
and Salmonella are associated with increased bloodstream infections,
increased hospitalization, and increased death.\8\ Recent outbreaks of
foodborne illness in produce like peppers and spinach are likely the
result of contamination by animal waste containing these bacteria
during the production and processing of crops.
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\7\ CDC. National Antimicrobial Resistance Monitoring System for
Enteric Bacteria (NARMS): Human Isolates Final Report, 2004. Atlanta,
Georgia: U.S. Department of Health and Human Services, CDC, 2007.
Online at http://www.cdc.gov/NARMS/NARMSAnnualReport2004.pdf.
\8\ Helms M., Simonsen J., Olsen K.E., M In 2003, the World Health Organization concluded, ``There is
clear evidence of the human health consequences [from
agricultural use of antibiotics, including] infections that
would not have otherwise occurred, increased frequency of
treatment failures (in some cases death) and increased severity
of infections.''
In 2003, National Academy of Sciences' Institute of Medicine
came to the same conclusion, stating, ``Clearly, a decrease in
antimicrobial use in human medicine alone will have little
effect on the current situation. Substantial efforts must be
made to decrease inappropriate overuse in animals and
agriculture as well.''
In 2001, the prestigious New England Journal of Medicine
published a special editorial whose title sums it up well--
``Antimicrobial Use in Animal Feed-Time to Stop.''
As a result of the mounting evidence, the American Medical
Association, American Academy of Pediatrics, American Nurses
Association, American Public Health Association, Infectious Diseases
Society of America, all endorse Federal legislation curtailing the use
of medically important drugs in animal agriculture.
Antibiotic Use in Healthy Animals Does Not Benefit Human Health
Despite the overwhelming concern by the medical community about the
human health, some experts associated with the animal industry, have
claimed that routine antibiotic use benefits human health by
suppressing pathogen levels in meat animals.\14\ There is simply no
evidence that that is the case. European studies have shown that levels
of foodborne pathogens in human isolates rise and fall independently of
antibiotic use in healthy food animals.\15\ U.S. experience that
directly contradicts the claim. from 1995 to 2000 there is documented
evidence of a significant drop in antimicrobial use on U.S. broiler
farms.\16\ During this same period, the surveillance by the CDC also
found a significant drop in the number of Campylobacter infections
directly contradicting the claims of antibiotic use proponents that any
reduction in antibiotic use will result in disease increases.\17\
Finally, an FDA administrative law judge considered a claim of an
animal health benefit of antibiotic use made in testimony to the
administrative law judge during proceedings adjudicating the
cancellation of Baytil. The judge rejected the claim because of lack of
evidence.\18\
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\14\ Cox L.A., Jr. Potential Human Health Benefits of Antibiotics
Used in Food Animals: A Case Study of Virginiamycin. Cox L.A., Jr.
Environ. Int. May 31, 2005 (4):549-63. There have been some published
risk assessments that make this claim. Most of these have as an author
Dr. Anthony Cox whose testimony was thrown out by the FDA in hearings
related to the withdrawal of the animal antibiotic Baytril because of
unreliability and lack of credibility.
\15\ Evans M.C., Wegener H.C. Antimicrobial Growth Promoters and
Salmonella spp., Campylobacter spp. in Poultry and Swine. Denmark.
Emerg. Infect Dis. 2003 April 9 (4):489-92.
\16\ Chapman H.D., Johnson Z.B. Use of Antibiotics and Roxarsone in
Broiler Chickens in the USA: Analysis for the Years 1995 to 2000.
Poult. Sci. March 2002. 81(3):356-64.
\17\ CDC. Preliminary FoodNet Data on the Incidence of Infection
with Pathogens Transmitted Commonly Through Food--10 States, 2006. MMWR
April 13, 2007/56(14); 336-339.
\18\ FDA. Final Decision of the Commissioner. Docket Number 2000N-
1571. Withdrawal of Approval of the New Animal Drug Application for
Enrofloxacin in Poultry. On line at http://www.fda.gov/oc/
antimicrobial/baytril.pdf.
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It Is Possible To Raise Livestock and Poultry With Fewer Antibiotics
The most direct and responsible antibiotic policy is to use
antibiotics judiciously where they are needed but eliminate uses that
are unnecessary. In human medicine, for example, physicians have
established guidelines against the use of antibiotics to treat viral
diseases, and aggressively seek to reduce prescriptions for those uses.
Animal agriculture offers an important opportunity to reduce the
pressure on the microbial ecosystem that creates resistance to
antibiotics used in animal agriculture. Most of the drugs used in
animal agriculture are used to promote growth and compensate for
crowded, stressful conditions characteristic of today's animal
production facilities. These uses can be reduce or eliminated with
modern husbandry practices. The viability of these practices has been
demonstrated in both industrial and alternative agricultural
operations. On the industrial side, Tyson was able to develop systems
for all of its retail chicken that used no antibiotics at all. On the
niche side, cattle grown out-of-doors and fed primarily grass rarely
need antibiotics. Many American producers, like Laura's Lean Beef,
Niman Ranch, Colemen are thriving in the market place selling beef and
pork produced without antibiotics.
Finally, the Europeans have shown that even industrial-style hog
and poultry operations can in ways that dramatically cut antibiotic
use.
In 1999, Denmark, the world's leading pork exporter, ended all use
of antimicrobial growth promoters. A World Health Organization (WHO)
analysis of the Danish experience has shown that ban with little or no
impact on agricultural productivity and animal welfare. The
comprehensive analysis, published in 2003, showed that there were no
appreciable impacts from the antibiotic ban in broiler chickens or
older, so-called ``finisher'' pigs. In young, so-called ``weaner''
pigs, there was a modest increase in the number of pigs requiring
antibiotics for the treatment of diarrhea, but the increase was
completely offset by the overall decrease in antibiotic use. According
to the WHO report, the overall drop in antibiotic use was 54 percent.
In the years following the ban, the Danish pig herd continued to grow
and the production losses associated with the ban in weaner pigs have
been overcome.\19\
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\19\ Wegener. Keynote Presentation. ASM Conferences Antimicrobial
Resistance in Zoonotic Bacteria and Foodborne Pathogens. June 15-18,
2008. Copenhagen, Denmark.
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The EU now has EU wide-ban on non-therapeutic antibiotics.\20\
Thailand \21\ and now Korea \22\ also have either enacted or will soon
enact bans on certain non-therapeutic antibiotic use.
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\20\ Ban on Antibiotics as Growth Promoters in Animal Feed Enters
Into Effect. Europa. December 22, 2005. Online at http://europa.eu/
rapid/pressReleasesAction.do?reference=IP/05/
1687&format=HTML&aged=0&language=EN&guiLanguage=en.
\21\ Brooks E. Reconciling Scarcity and Demand through Innovation.
FBA Issue 21. July/August 2008. Online at http://www.efeedlink.com/
ShowDetail/03c885e3-7852-439a-9ef0-a8a0b66a749c.html.
\22\ Tae-jong K. Antibiotics to Be Banned for Feeding Animals. The
Korea Times. August 8, 2008. Online at http://www.koreatimes.co.kr/www/
news/nation/2008/09/117_30326.html.
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The actions taken in other countries are important because they
validate the public health problem demonstrate that antibiotic can be
reduced in commercially acceptable ways. In addition, the point to
potential trade challenges the U.S. may encounter in the future if it
fails to limit such uses here in the U.S.
As warned in a GAO report from 2004,\23\ these countries also
represent potential challenges to the U.S. products in the global
marketplace. Under the trade rules, countries can restrict imports that
do not conform to certain rules, provided they adhere to those rules
themselves. For example, Korea could potentially restrict imports that
relied on medicated feed not allowed in Korea. The greater the number
of export partners that adopt such bans, the more vulnerable our meat
exports in the global marketplace.
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\23\ Antibiotic Resistance: Federal Agencies Need to Better Focus
Efforts to Address Risk to Humans from Antibiotic Use in Animals, GAO-
04-490, April 22, 2004. Online at http://www.gao.gov/docsearch/
locate?to=http%3A%2F%2Fwww.gao.gov%2Fnew.items%2Fd04490.pdf.
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And as further noted by the GAO report,\24\ if any major importer
were to restrict trade from the U.S. because of the use of
nontherapeutic antibiotics that would override any economic benefits of
this practice. In addition, the U.S. currently is failing to follow
Codex recommendations \25\ by continuing the use of antibiotics as
growth promoters.
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\24\ Antibiotic Resistance: Federal Agencies Need to Better Focus
Efforts to Address Risk to Humans from Antibiotic Use in Animals, GAO-
04-490, April 22, 2004. Online at http://www.gao.gov/docsearch/
locate?to=http%3A%2F%2Fwww.gao.gov%2Fnew.items%2Fd04490.pdf.
\25\ Code of Practice to Minimize and Contain Antimicrobial
Resistance. CAC/RCp 61-2005. Online at http://
www.codexalimentarius.net/download/standards/10213/CXP_061e.pdf.
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The U.S. animal agriculture industry is at risk of following the
example of the U.S. auto industry and failing to see where the market
is going. Increasingly, consumers are seeking meat from animas raised
without these antibiotics. International competitors are beginning to
meet this demand. In addition to protecting public health, minimizing
antibiotics use in livestock can help U.S. producers add consumer value
to their products, and position themselves advantageously in the global
marketplace. American producers should be supported in reducing their
antibiotics use. KAW believes that research, extension, and outreach
are critically important to helping producers adopt livestock
management techniques that are less dependant on antibiotic use.
______
Submitted Statement of Karen Steuer, Director of Government Operations,
Pew Campaign on Human Health and Industrial Farming
The Campaign on Human Health and Industrial Farming, of the Pew
Charitable Trusts, appreciates this opportunity to submit testimony for
the record regarding the use of antimicrobials in the livestock
industry and important related human health issues.
As the Subcommittee is aware, food animals in intensive production
in the United States are commonly treated with antibiotics to prevent
the transfer of bacteria and infections in the crowded and sometimes
unhygienic conditions of many industrial farms. Such therapeutic
treatment of disease is critical to maintaining animal health. However,
antibiotics are also commonly used in livestock to promote growth and
rapid weight gain, and to prevent disease in the crowded conditions of
industrial farms.
This nontherapeutic administration of antibiotics was studied
closely by national health and agricultural experts who served on the
Pew Commission on Industrial Farm Animal Production. In April 2008, the
Commission issued a final report and called for stricter regulation of
antibiotic use in industrial farm animals and articulated serious
concerns about the nontherapeutic application of certain drugs in
animals. Entire herds or flocks of farm animals are routinely fed
antibiotics at low levels in their feed or water--a practice that has
been identified as a major contributor to antibiotic resistance by
human health professionals and organizations worldwide. For example:
In the July, 2003, issue of Pediatrics: Official Journal of
the American Academy of Pediatrics Dr. Katherine Shea
concludes, ``There is a long-standing debate over the exact
role that agricultural use of antimicrobials plays in the
current antibiotic resistance crisis. Although data gaps
complicate the debate somewhat, existing evidence proves that
part of the crisis is caused by antimicrobial use in
livestock.'' \1\
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\1\ Shea, K. (2003). Antibiotic Resistance: What is the Impact of
Agricultural Uses of Antibiotics on Children's Health? Pediatrics, 112
(1), 253-258.
In 2000, the World Health Organization warned, ``National
governments should adopt a proactive approach to reduce the
need for antimicrobials in animals and their contribution to
antimicrobial resistance and to ensure their prudent use
(including reducing overuse and misuse), as elements of a
national strategy for the containment of antimicrobial
resistance,'' and further recommended that ``Use of
antimicrobial growth promoters that belong to classes of
antimicrobial agents used (or submitted for approval) in humans
and animals should be terminated or rapidly phased-out in the
absence of risk-based evaluations. The termination or phasing-
out should be accomplished preferably by voluntary programmes
of food animal producers, but by legislation if necessary.''
\2\
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\2\ World Health Organization. (2000). WHO Global Principles for
the Containment of Antimicrobial Resistance in Animals Intended for
Food. Geneva. At: http://www.who.int/salmsurv/links/en/
GSSGlobalPrinciples2000.pdf.
The Centers for Disease Control and Prevention (CDC)
observed, ``Resistant bacteria may be transferred to humans
through the food supply or direct contact with animals. For
example, Campylobacter lives in the intestines of chickens.
People get Campylobacter diarrhea primarily from eating
undercooked chicken. In 1989, none of the Campylobacter strains
from ill persons that CDC tested were resistant to
fluoroquinolone antibiotics. In 1995, the FDA approved the use
of fluoroquinolones in poultry. Soon afterwards, doctors found
Campylobacter strains from ill persons that were resistant to
fluoroquinolone antibiotics.'' \3\
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\3\ Centers for Disease Control and Prevention (CDC). National
Antimicrobial Resistance Monitoring System (NARMS) Frequently Asked
Questions (FAQ) About Antibiotic Resistance--How do resistant bacteria
spread from animals to humans? At: http://www.cdc.gov/narms/faq_pages/
12.htm.
Many antibiotics that are used in food animal production belong to
the same classes that are used to treat humans. These include
tetracyclines, penicillins, cephalosporins, macrolides, and
fluoroquinolones, among others.\4\ The similarity between human and
animal drugs frequently means that bacteria resistant to antibiotics
used in animals also are likely to be resistant to those used in
humans.
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\4\ FDA Center for Veterinary Medicine, Database of Approved Animal
Drugs, at http://dil.vetmed.vt.edu/NADA/.
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The public health implications of antibiotic-resistant bacteria go
far beyond the immediate threat of infection. Because the infection
lingers while an effective antibiotic is identified, the potential for
more severe illnesses and transmission to others is greatly increased.
This is troubling for our already besieged public health care system
for a number of reasons. More severe illnesses result in both higher
frequency and longer duration of hospitalizations, raising the cost of
health care. In 1998, the Institute of Medicine estimated that
antibiotic-resistant bacteria generated an estimated $4-$5 billion per
year in extra costs to the U.S. health care system,\5\ and it is likely
these costs have increased over time. There is also an overall higher
risk of complications and death as there are fewer effective drugs
available to treat serious infections.
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\5\ Institute of Medicine. (1998). Antimicrobial Resistance: Issues
and Options. Workshop Report, Forum on Emerging Infections. (P.F.
Harrison, & J. Lederberg, Eds.) Washington, D.C.: National Academy
Press.
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Corporate food industry representatives have raised concerns that
any change in antibiotic use will contribute to already increasing food
prices. However, two recent large-scale studies--one with poultry and
one with swine--found that the actual economic benefits were miniscule
to nonexistent, and that the same financial benefits could instead be
achieved by improving the management of the animals.\6\ Even when
improvements from growth promoting antibiotics have been observed,
their benefits are completely offset if costs from increased resistance
are considered: loss of disease treatment options in humans and
animals, increased health care costs, and more severe and enduring
infections. These costs are unfairly externalized to American consumers
and the health care system at a time when neither can afford it.
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\6\ Graham J.P., Boland J.J., Silbergeld E. ``Growth promoting
antibiotics in food animal production: an economic analysis.'' Public
Health Rep. 2007; 122:79-87; and Miller G.Y., Algozin K.A., McNamara
P.E., Bush E.J. ``Productivity and economic effects of antibiotics use
for growth promotion in U.S. pork production.'' Journal of Agricultural
and Applied Economics 2003; 35:469-482.
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Other countries that are important U.S. trading partners have
banned or are currently taking steps to phase out the nontherapeutic
use of antimicrobials in animal agriculture, such as the European
Union, Denmark, Sweden, and South Korea. Denmark became the first
country with a large livestock industry to ban antibiotic growth
promoters in 1998. According to a World Health Organization (WHO) 4
year review of the impact of the ban, Denmark achieved its goals: total
antibiotic use in pigs and poultry was down 54% in 2001 from its peak
in 1994 (despite some initial increase in therapeutic antibiotic use in
weaner pigs), and drug-resistant strains of bacteria that are harmful
to human health fell sharply in animals and meat.\7\ As a result, the
WHO concluded, ``Under conditions similar to those in Denmark, the use
of antimicrobials for the sole purpose of growth promotion can be
discontinued.'' \8\
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\7\ World Health Organization. (2003.) Impacts of antimicrobial
growth promoter termination in Denmark. Foulum, Denmark. At: http://
www.who.int/salmsurv/en/Expertsreportgrowthpromoterdenmark.pdf.
\8\ Ibid, p. 8.
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Action is urgently needed to address emerging antibiotic
resistance, and should not be weighed in the context of a few pennies
per chicken breast or pork chop against the growing health risks faced
by thousands of Americans contracting antibiotic-resistant infections
annually. According to the Infectious Diseases Society of America,
90,000 people die each year of a hospital-acquired infectious disease.
Of these individuals, an estimated 70% have infections that are
resistant to at least one antibiotic drug.\9\
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\9\ Infectious Diseases Society of America. (July 2004). Bad Bugs,
No Drugs. As Antibiotic Discovery Stagnates . . . A Public Health
Crisis Brews. Alexandria, VA. At: http://www.idsociety.org/WorkArea/
showcontent.aspx?id=5554.
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The most critical step to ensure the availability and efficacy of
antimicrobial drugs is to create policies that drastically reduce their
use where they are being applied most inappropriately and in the
greatest numbers: in the production of our food supply. The Pew
Campaign on Human Health and Industrial Farming supports the Preserving
Antibiotics for Medical Treatment Act (H.R. 962), which would ban the
routine, non-therapeutic use of antibiotics in industrial animal
production unless drug manufacturers can demonstrate that there is no
harm to human health due to the development of antibiotic resistance.
Pew is not alone in this approach.
In 2007 the American Public Health Association (APHA) issued
the following policy statement: ``APHA recognizes the urgency
of transforming our food system to promote environmental
sustainability, improve nutritional health, and ensure social
justice, and therefore--Urges Congress to . . . Ban
nontherapeutic antimicrobial use and arsenic use and increase
funding for surveillance and research on antimicrobial
resistance in healthy animals and ensure public health
oversight of animal feed ingredients.'' \10\ This policy came
upon the heels of an earlier recommendation by the APHA that
``Urges the Center of Veterinary Medicine of the FDA to work
for regulations eliminating the non-medical use of antibiotics
and limiting the use of antibiotics in animal feeds.'' \11\
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\10\ American Public Health Association (APHA). (November 6, 2007.)
Toward a Healthy, Sustainable Food System. At: http://www.apha.org/
advocacy/policy/policysearch/default.htm?id=1361.
\11\ APHA. (January 1, 1999.) Addressing the Problem of Bacterial
Resistance to Antimicrobial Agents and the Need for Surveillance. At:
http://www.apha.org/advocacy/policy/policysearch/default.htm?id=179.
In 2006, the Infectious Diseases Society of America
announced their policy of giving ``high priority to the
following strategies in the belief that support for these
efforts will most rapidly achieve control of the problem of
antibiotic resistance and/or provide the scientific basis to
manage it in a rational manner. Support for legislation to
phase out nontherapeutic use of certain antimicrobial drugs in
food animals, including all antimicrobial drugs classified as
'critically important' or 'highly important' for human
therapeutic use by the Food and Drug Administration.'' \12\
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\12\ Infectious Diseases Society of America. (April 24, 2006.)
Principles and Strategies Intended to Limit the Impact of Antimicrobial
Resistance. At: http://www.idsociety.org/WorkArea/
downloadasset.aspx?id=4042.
In 2002, the American College of Preventative Medicine
adopted a resolution endorsing ``efforts to curb the growing
public health threat of antibiotic resistance by reducing the
overuse and misuse of antibiotics in both agriculture and human
medicine; phasing out the use in healthy farm animals of
antibiotics used in human medicine or closely related to human
drugs; efforts to promote sustainable agricultural production
methods that provide alternatives to the use of antibiotics in
healthy farm animals,'' and to ``Urge companies involved in the
production of meat, poultry and fish to voluntarily agree to
stop using nontherapeutic antibiotics (i.e., those used for
purposes other than treating sick animals), and we urge
companies and individuals that purchase meat, poultry and fish
products to seek products that have been produced without
nontherapeutic antibiotics.'' \13\
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\13\ American College of Preventive Medicine. (January 23, 2002.)
Policy Resolution #05-02(A): Principles for Combating Antibiotic
Resistance. At: http://www.acpm.org/
pol_winter2002res.htm#Principles%20for%20Combating%20Antibiotic%20Resist
ance.
In 2001, the American Medical Association adopted a policy
to ``oppose the use of antimicrobials at non-therapeutic levels
in agriculture, or as pesticides or growth promoters, and urge
that non-therapeutic use in animals of antimicrobials (that are
also used in humans) should be terminated or phased out based
on scientifically sound risk assessments . . .'' \14\
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\14\ American Medical Association. (June 2001). Resolution 508:
Antimicrobial Use and Resistance, 2001 Annual Meeting Proceedings. At:
http://www.ama-assn.org/meetings/public/annual01/resolutions.pdf.
In 1999 the Council of State and Territorial
Epidemiologists, National Association of State Public Health
Veterinarians adopted a position recommending ``the
discontinuation of antimicrobials used to promote the growth of
food animals if they are also used in human medicine. These
uses may increase antimicrobial resistance and no longer meet
the food safety criteria of reasonable certainty of no harm.''
\15\
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\15\ Council of State and Territorial Epidemiologists. (1999.) CSTE
Position Statement 1999-ID 7: Discontinuation of Antimicrobials Used to
Promote Growth of Food Animals if they are used in or Select for Cross
Resistance to Antimicrobials used in Human Therapy. At: http://
www.cste.org/ps/1999/1999-id-07.htm.
Given the concerns raised by these and other human health
professionals, it is the view of the Pew Charitable Trusts that
Congress must address the looming crisis posed by antibiotic
resistance, and the contribution to that crisis of nontherapeutic
antibiotic use in industrial animal agriculture. Congress should also
examine the growing body of evidence indicating that farm workers and
farm communities are at risk of exposure to resistant bacteria that
either originate on industrial farms or are carried by the animals on
those farms.\16\-\18\
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\16\ Gilchrist, M.J., C. Greko, D.B. Wallinga, G.W. Beran, D.R.
Riley, & P.S. Thorne. (February 2007.) The Potential Role of
Concentrated Animal Feeding Operations in Infectious Disease Epidemics
and Antibiotic Resistance. Environmental Health Perspectives, 115 (2).
\17\ van Rijen, M.M.L., P.H. Van Keulen, & J.A. Kluytmans. (January
2008.) Increase in a Dutch Hospital of Methicillin-Resistant
Staphylococcus aureus Related to Animal Farming. Clinical Infectious
Diseases, 46 (2): 261-263.
\18\ Price, L.B., J.P. Graham, L.G. Lackey, A. Roess, R. Vailes, &
E. Silbergeld. (December 2007.) Elevated Risk of Carrying Gentamicin-
Resistant Escherichia coli among U.S. Poultry Workers. Environmental
Health Perspectives 15 (12).
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We urge the Agriculture Committee and all Members to take these
grave health concerns into account and to address this important issue
in the next Congress, in particular during consideration of important
legislative initiatives related to food safety and health care reform.
The Pew Charitable Trusts looks forward to working with the House
Committee on Agriculture Members and staff to find practical, workable
solutions to this public health threat, while protecting the necessary
and valuable therapeutic uses of antimicrobials in order to maintain
animal wellbeing and human health.
For additional information, please feel free to contact me at
[Redacted], or at [Redacted].
______
Submitted Statement of Robert P. Martin, Executive Director, Pew
Commission on Industrial Farm Animal Production
Mr. Chairman and Members of the House Agriculture Subcommittee on
Livestock, Dairy, and Poultry, my name is Robert Martin and I was the
Executive Director of the Pew Commission on Industrial Farm Animal
Production. I appreciate the opportunity to submit a brief statement on
the Commission's recommendations on antimicrobial use in industrial
farm animal production.
The Pew Commission on Industrial Farm Animal Production was a 2
year study funded by a grant from The Pew Charitable Trusts to
recommend solutions to the public health, environmental, animal
welfare, and rural community problems created by industrial animal
agriculture.
The Commission released its final report in April of 2008 that
included 24 primary recommendations, and several secondary
recommendations, in the four general areas studied. Of those 24
recommendations, 12 addressed public health problems, and five of those
addressed antibiotic use in industrial animal agriculture.
The first recommendation on antimicrobial use is to restrict the
use of antimicrobials in food animal production to reduce the risk of
antimicrobial resistance to medically important antibiotics. That is to
be accomplished by: (1) Phase out and ban use of antimicrobials for
nontherapeutic use in food in food animals; (2) Immediately ban any new
approvals of antimicrobials for nontherapeutic uses in food animals and
retroactively investigate microbials previously approved; (3)
Strengthen recommendations in the Federal Drug Administration's
Guidance 152; and (4) Educate producers on how to raise animals without
the reliance on nontherapeutic use of antibiotics and other
antimicrobials.
Perhaps equally important are the Commission's definitions of
therapeutic, nontherapeutic, and prophylactic use of antimicrobials.
Present definitions used by the animal agriculture industry blur the
distinctions between these categories, often calling ``nontherapeutic''
use ``prophylactic'' use.
The Commission defines nontherapeutic use as any use of
antimicrobials in food animals in the absence of microbial disease or
documented (known) microbial disease exposure. Any use of the drug as
an additive for growth promotion, feed efficiency, weight gain, routine
disease prevention in the absence of documented exposure, or other
routine purposes, is considered nontherapeutic.
Therapeutic use is defined by the Commission as the use of
antimicrobials in food animals with diagnosed microbial disease, that
is, sick animals. This definition is very important given some of the
inaccurate comments made during the Subcommittee hearing on September
25, 2008. At no time has the Commission called for banning the use of
antibiotics in sick animals, as was claimed by witnesses and some
Members of the Subcommittee. A recommendation banning the medical use
of antibiotics in food animals would be irresponsible and indefensible.
The Commission defines prophylactic as the use of antimicrobials in
healthy animals in advance of an expected exposure to an infectious
agent or after such an exposure but before the onset of a laboratory-
confirmed clinical disease as determined by a licensed professional.
Claims that the Commission proposed banning the use of all
antibiotics in animal agriculture, or that it did not want
veterinarians to have access to medicine to treat sick animals, do not
add to the serious discussion of the issue. Nothing is further from the
truth about the Commission recommendations. The Commission's
recommendations on antimicrobial use are an attempt to use these
important live saving drugs--for people and animals--in a more
appropriate way to help preserve their effectiveness.
It is commonly accepted now that all use of antibiotics adds to the
problem of antibiotic resistance. Concern about the prudent, medical
use of antibiotics in human medicine began at least 30 years ago. It is
time to do the same in animal agriculture, since estimates indicate
that as much as 70% of the antibiotics used in the United States are
used in food animals.
Thank you.
Robert P. Martin,
PCIFAP.
______
Supplemental Material Submitted By National Pork Producers Council
Introduction
The National Pork Producers Council is an association of 43 state
pork producer organizations and serves as their voice in Washington,
D.C.
U.S. pork producers appreciate the opportunity to reiterate their
antibiotic responsible use guidelines and to address statements made
about Methicillin-resistant Staphylococcus aureus (MRSA) and animal
agriculture.
Pork Industry Developed Guidelines on Antibiotic Use
U.S. pork producers take the use of antibiotics very seriously. Our
ethical principles specifically address animal-health products because
we believe all producers need to use antibiotics judiciously and
responsibly to protect pig health, to produce safe pork and manage
antibiotic use to protect public health.
This obligation to protect animal health and public health is why
U.S. pork producers developed our responsible antibiotic use program,
``Take Care--Use Antibiotics Responsibly.'' It was the first producer
program outlining principles and guidelines that protect public health,
animal health and animal well-being through the responsible use of
antibiotics. ``Take Care'' is the product of cooperation among
producers, veterinarians, the feed industry, Federal public health
agencies and food companies. The pork industry's responsible-use
program has been praised by many Federal agencies, legislators,
consumer organizations and food supply companies. The U.S. pork
industry developed this program because it was the right thing to do.
Like all Americans, pork producers care about animal health and public
health.
Initially, ``Take Care'' started as a voluntary program, and many
producers participated. Today, however, the pork industry understands
how important it is to use antibiotics responsibly, and ``Take Care''
is the way the U.S. pork industry does business. It's good for our
pigs, it's good for our producers and families, and it's good for the
bottom line. ``Take Care'' has been incorporated into the industry's
Pork Quality Assurance (PQA) Plus program, which includes on-farm
assessments, including reviews of whether the antibiotic-use principles
are being practiced. Producer PQA Plus certification is required by
U.S. packing plants as a condition of sale.
The veterinarians working in the U.S. pork industry also have been
proactive in the responsible use of antibiotics. The American
Association of Swine Veterinarians was the first species-specific
veterinary organization to collaborate with FDA and the American
Veterinary Medical Association to create and endorse judicious-use
guidelines for antibiotics.
MRSA
While MRSA has been found in pigs, it likely has little to do with
the human epidemic in the U.S. or the use of antibiotics in pig herds.
It be should be noted that Denmark, a country that has banned
antibiotics growth promoters in 1999, has a high prevalence of swine
herds that are positive for MRSA. According to the Centers for Disease
Control and Prevention (CDC), MRSA in the U.S. is largely human health
care related. When it comes to community acquired infections, CDC says
it has investigated numerous outbreaks of community-associated MRSA
infections in the U.S., and in none of these investigations has animal
exposure been identified as a risk factor for infection. Although the
finding of MRSA in retail meat suggests a possible role for foodborne
transmission, it likely accounts for a very small proportion of human
infections in the U.S., if the transmission does indeed occur.
The MRSA found in pigs does not cause illness in these animals and
does not require pork producers to use antibiotics to control it. The
presence and further development of antibiotic-resistant strains of
bacteria is a serious concern for society. The scientific community,
including physicians and veterinarians, continues to work to understand
how antibiotic use for humans and on livestock farms, such as swine
operations, contributes to antibiotic resistance. Once again, the pork
industry supports judicious use of antibiotics, which are essential to
the health and well-being of animals.
A letter from Dr. Julie Gerberding of the CDC to the House
Committee on Agriculture is submitted along with this statement. (This
document is located on p. 113.)
Summary
Pork producers and veterinarians have a moral obligation to use
antibiotics responsibly to protect human health and provide safe food,
both of which are paramount concerns to America's pork producers.
Producers also have an ethical obligation to maintain the health of
their pigs. Antibiotics are merely one piece to the health care system
that pigs need. The U.S. pork industry has a long history of being
proactive and doing the right thing for its pigs and consumers. Pork
producer developed ``Take Care'' and PQA Plus not because they had to
but because it was the right thing to do. The U.S. pork industry
continues to adopt better techniques and new technologies, but it
cannot lose the tools it already has developed, including antibiotics,
to protect the well-being of producers' animals and to produce safe
pork.
______
Supplemental Material Submitted By Richard A. Carnevale, V.M.D., Vice
President, Scientific, Regulatory and International Affairs, Animal
Health Institute
October 8, 2008
Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.
Dear Mr. Chairman:
I am writing to address testimony presented by Representative
Louise M. Slaughter to this Subcommittee at the hearing on Advances in
Animal Health within the Livestock Industry on the use of
antimicrobials in animal agriculture. I am Dr. Richard Carnevale of the
Animal Health Institute and testified before you at this hearing. I
greatly appreciated the opportunity to present the views of the animal
health industry.
Antibiotic resistance is clearly a public health concern, as
Representative Slaughter points out. However, it is widely accepted
that the major resistance problems in human medicine are due to human
use of antimicrobials and that the contribution from the use of
antimicrobials in food animals has been greatly exaggerated. The
majority of diseases in human medicine and those Representative
Slaughter mentions as important uses for antimicrobials do not come
from animals. A survey of medical specialists in Europe and the U.S.
concluded that use of antimicrobials in livestock might contribute to
only 4-5% of resistance problems encountered in human medicine.\1\
Furthermore, we are not aware of any studies that have ``. . .
conclusively linked non-therapeutic use to a growing number of
incidents of antimicrobial-resistant infections in humans.'' as Ms.
Slaughter contends.
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\1\ Bywater R. and Casewell M. Assessment of the impact of
antimicrobial resistance in different bacterial species and of the
contribution of animal sources to resistance in human infection.
Journal of Antimicrobial Chemotherapy 2000; 6: 643-645.
---------------------------------------------------------------------------
AHI surveys of the it's antimicrobial producing member companies
every year indicates that about 5% of all antimicrobials sold for food
animals are used for ``non-therapeutic use'' to increase weight gain or
decrease feed consumption. The vast majority of antimicrobials are used
to prevent, control, and treat animal diseases which are all considered
therapeutic uses by the American Veterinary Medical Association and the
international food standard setting organization, the Codex
Alimentarius.
It is also misleading to suggest that the well publicized
infections in schools and athletic facilities caused by Methicillin
Resistant Staphylococcus Aureus (MRSA) are due to use of antimicrobials
in animals. It is true that a strain of MRSA has been isolated from
pigs in Canada and some European countries , but this strain is not the
same bacterial pathogen that is responsible for either hospital or
community MRSA infections in the United States. Dr. Julie Gerberding,
Director of the Centers for Disease Control and Prevention, recently
wrote to House Agriculture Committee Chairman Collin Peterson on MRSA
and its connection to animal agriculture. In none of the investigations
that CDC has conducted on outbreaks of community-associated MRSA
infections has animal exposure been identified as a risk factor.
Furthermore, they have found ``. . . no documented role for meat
consumption or handling in the transmission of MRSA.'' We have attached
the CDC letter to the Chairman for your information.
Two other points in her testimony require comment. In fact,
language inserted in the farm bill to facilitate research on
antimicrobial use and resistance was included in the final version.
Section 7521 of P.L. 110-246, the farm bill, requires the Secretary to
provide research and education grants to study the development of
antibiotic resistant bacteria and to ensure the judicious use of
antibiotics in veterinary and human medicine.
Second, the Animal Drug User Fee Act of 2008 included a specific
provision that requires FDA to collect from animal drug application
sponsors and report on antimicrobial sales data beginning in 2010. The
industry supported this amendment and provided technical guidance to
the House Energy and Commerce Committee in developing the necessary
language in the ADUFA bill.
Mr. Chairman, the bill that Congresswoman Slaughter endorses, H.R.
962, the Preservation of Antibiotics for Medical Treatment Act (PAMTA)
would do nothing to curb antimicrobial resistance problems in human
medicine but will likely have adverse consequences to animal health and
food safety, while increasing feed and food costs. As I testified
before your Subcommittee, FDA already has a rigorous science-based
process for determining the safety of antimicrobials used in food
animals and this process has at its foundation, risk assessment. Risk
assessments have and continue to be conducted on several antimicrobials
used in food-producing animals. Those assessments have indicated that
the risks of antimicrobial resistance being transferred to humans and
impacting public are quite low and certainly do not justify wholesale
removal of safe and effective products important to animal agriculture.
I thank you for the opportunity to provide further comment on this
important topic.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Attachment
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Question. In your testimony you outlined human public health
numbers. How many livestock-bacterial infections are there in the
United States? What is the percentage of those infections that are
associated with bacterial pathogens displaying antimicrobial
resistance?
Answer. This is a challenging question to attempt to answer, as
Salmonellae are the only animal bacterial pathogens covered by a
surveillance program that includes evaluating antimicrobial resistance.
The National Animal Health Monitoring System (NAHMS) collects
information through periodic (at 5-10 year intervals) national surveys
on the occurrence of disease in animal populations on farms. However,
these data are normally collected without regard to the etiologic agent
causing the disease. Instead, the program collects data on the
occurrence of disease syndromes in animal groups (usually specific age
groups). For example, national estimates are available on the
proportion of dairy calves prior to weaning that experience a digestive
disease problem. The program does not differentiate digestive disease
caused by bacteria (such as Escherichia coli or Salmonella) from
disease caused by viruses (such as Rotavirus or Corona virus) from
disease caused by parasites (such as Cryptosporidium).
So, while we do estimate the number of calves affected by ``a
digestive disease'' we cannot say how many of these are associated with
bacterial etiologies let alone how many of these are caused by
organisms that are resistant to one or more antimicrobial drugs.
The NAHMS program has some information for Salmonella based on
samples collected on farm from healthy animals. These samples have been
collected for some animal species including cattle (beef cow-calf,
feedlot, and dairy) and swine. Data on other commodities and companion
animals are lacking. One of the primary benefits of this sampling has
been to partially characterize the potential risk to food safety. The
sampling of healthy animals (i.e., those that are likely to end up in
the food chain) has progressed toward this benefit.
Veterinary diagnostic laboratories also receive samples collected
from ill animals on the farm. Which factors affect the decision of the
producer and/or veterinarian to submit samples to the diagnostic
laboratory is not clear and therefore it is unknown how this population
relates to all of the animals that become ill on farms. Factors such as
the number of animals affected, the severity of the disease, the
availability and interest of a veterinarian and individual animal
economic value could all affect the decision to submit a sample to
obtain a diagnosis. If a bacterial agent is identified from the case
material it may or may not be tested for susceptibility to
antimicrobial drugs. The cases from which samples are submitted have
frequently (though the extent and history is often unknown) been
treated with antimicrobial drugs. from the above it should be clear
that the diagnostic laboratory data are not representative of all ill
animals on farm (though the extent is not known), representing the
worst case scenario, i.e., animals that have failed to respond to
standard empirical treatments. In addition to the issues associated
with sample representativeness and the decision to test for
susceptibility there is no central repository of information for the
findings on antimicrobial susceptibility for animal pathogens. Some
diagnostic laboratories may publish annual summaries for the clientele
but there is no entity that collates the information, validates it and
interprets it to produce information for producers, veterinarians or
diagnosticians.
Response from Stephen R. Mason, Acting Assistant Commissioner for
Legislation, Food and Drug Administration, U.S. Department of
Health and Human Services
Nov. 20, 2008
Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.
Dear Mr. Chairman:
Thank you for providing an opportunity for the Food and Drug
Administration (FDA or the agency) to testify at the September 5,2008,
hearing before the House Agriculture Committee's Subcommittee on
Livestock, Dairy and Poultry. The hearing addressed advances of animal
health within the livestock industry.
This letter provides responses for the record to questions you
raised during the hearing. We have reprinted the questions below,
followed by the agency's response.
Question 1. What are the costs associated with getting an animal
drug approved for market?
Answer. In Fiscal Year (FY) 2007, FDA's organizational components
spent $49,588,801 in process costs, as described in the Animal Drug
User Fee Act (ADUFA), associated with the review of new animal drug
applications. Additional details related to FDA's costs for reviewing
animal drug applications are provided on page 9 of the enclosed FY 2007
ADUFA Financial Report.
If your question relates to industry's developmental, application,
and other costs associated with animal drug applications, drug sponsors
are better able than FDA to provide such data.
Question 2. How many livestock bacterial infections are there in
the U.S.? What percentage of those infections is associated with
bacterial pathogens displaying antimicrobial resistance?
Answer. FDA considers information on bacterial infections in
livestock and on potential resistance to antimicrobial drugs of the
pathogens that cause such infections in the context of evaluating
specific new animal drug applications (NADA). Such information is
generally supplied by the sponsor of the NADA and is specific to the
intended use of the drug in question. FDA does not conduct routine
national surveys of bacterial diseases in livestock. Therefore, we are
unable to provide data on the overall number of bacterial infections in
U.S. livestock or on the percentage of those infections displaying
antimicrobial resistance.
FDA recognizes that bacterial diseases in livestock are important
public and animal health challenges. FDA is taking an increasingly
active role with our partners at the United States Department of
Agriculture and the Centers for Disease Control and Prevention to study
livestock bacterial diseases, including Escherichia coli. It is hoped
that these joint efforts can lead to a greater understanding of the
diseases themselves and how best to address and control them.
Thank you again for the opportunity to appear before the
Subcommittee. Please let us know if you have any further questions or
concerns.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Acting Assistant Commissioner for Legislation.
Attachment 1
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.
Dear Mr. Chairman:
Thank you for your letter of July 10, 2008, cosigned by Ranking
Member Robin Hayes, Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture. You wrote to express your concern about the
potential lack of funding for the Food Animal Residue Avoidance
Database (FARAD) program. In your letter, you requested that the United
States Department of Agriculture (USDA) and the Department of Health
and Human Services (HHS) work together to ensure funding for the
program's continuation.
As you know, Title 7 of the United States Code, section 7462 gives
the Secretary of Agriculture responsibility for the operation of FARAD.
USDA operates this program through the Cooperative State Research,
Education, and Extension Service. It is our understanding that, in
Fiscal Year 2008, there were no appropriated funds available to support
this program. USDA and HHS have worked together to provide partial
funding. USDA has agreed to contribute $75,000, and the Food and Drug
Administration has agreed to contribute $50,000 to support the program.
Thank you again for your letter. Please call me if you have any
further questions or concerns. The same letter has been sent to Ranking
Member Hayes.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Acting Assistant Commissioner for Legislation.